CA 15-3™ RIA (radioimmunoassay) serum tumor marker

Serum tumor-marker assay indicated for use in monitoring and detection of disease recurrence in patients with stage III breast cancer. Mfg: Centocor.

Clinical trials of cA2 monoclonal antibody have demonstrated a 50% closure rate of enterocutaneous fistulae in patients suffering from this complication of Crohn disease. Developed by Centocor.

See Cardiology/Cardiovascular Operative Reports.

A 3.0-mm catheter indicated for introduction of contrast media into the uterus. See GyneSys® Dx diagnostic catheter system.

See Cardiology/Cardiovascular Operative Reports.

High-energy, single-lead, defibrillator for treatment of cardiac arrhythmias, provides 42 joules of stored energy and 16 minutes of continuous electrogram storage as a diagnostic aid. Mfg: Ventritex.

A computerized 3-dimensional treatment planning system for cancer therapy. See manufacturer's specification sheet. Mfg: Varian Associates, Inc.

CAESAR (Canada, Australia, Europe, South Africa) AIDS trial, investigating the use of lamivudine with combination regimens that also include zidovudine, has shown promising results with the slowing of the progression of the disease with improved survival.

Indication: short-term treatment of apnea of prematurity (AOP) in infants between 28 and <33 weeks gestational age. Treatment started in the hospital with Cafcit injection can be continued by caregivers at home with Cafcit oral solution. See product monograph for details. Mfg: Roxane Laboratories, subsidiary of Boehringer Ingelheim

Calgiswab™

Calcium alginate swab used in microbial sampling, throat cultures, routine gynecological screening, etc. See Calgiswab type 2 and Calgiswab type 3. Mfg: Spectrum Medical.

Obstetrical system utilizes a network of computers and software for monitoring labor and fetal status. The system also accesses database and archived information of similar labor progress for comparison with the patient's status in order to guide patient care during labor. Mfg: LMS Medical Systems Limited.

Rapid exchange PTCA balloon angioplasty catheter with low-profile design and available in 38 sizes. Mfg: C. R. Bard.

Name being considered to replace the generic name amiodarone; see amiodarone entry.

Investigational agent for the treatment of chronic lymphocytic leukemia (CLL) refractory to standard therapies (alkylating agents, fludarabine). Campath is a humanized monoclonal antibody to the leukocyte antigen CD52, which is expressed on lymphocytes and which is not detected on hematopoietic stem cells, designed to combat CLL by selectively depleting lymphocytes. In clinical trials; BLA (biologic license application) planned for mid-1999. Jointly developed by LeukoSite, Inc. and ILEX Oncology, Inc.

Expanded indication: use in combination with 5-fluorouracil/leucovorin (5-FU/LV) as first-line therapy for the treatment of patients with metastatic colorectal cancer. Camptosar was initially introduced in 1996 and received full FDA approval in 1998 as second-line therapy, i.e., the treatment of patients with metastatic cancer of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. See monograph for additional information. Clinical studies are being conducted to evaluate Camptosar in conjunction with 5-FU/LV in the treatment of earlier stage colon cancer and it is also being developed for the treatment of other cancers such as cancer of the lung and pancreas. Mfg: Pharmacia Corporation.

An oral vaccine consisting of an inactivated whole-cell Campylobacter preparation for use in the prevention of gastroenteritis, diarrhea, and traveler's disease caused by Campylobacter. Vaccine is entering phase III clinical trials funded and conducted by the U.S. Navy. Mfg: Antex Biologics Inc.

See ScleroLASER, ScleroPLUS, and Lasers. Mfg: Candela.

An oral antibody product in development for the treatment of thrush in AIDS patients. Mfg: GalaGen Inc.

OTC combination of herbs and nutrients to combat Candida and replenish the intestinal system with beneficial bacteria. Candistroy, marketed under the Nature's Secret® brand name, is available through health food outlets such as GNC. Mfg: 4Health Inc.

A double-blind, multicenter, randomized study to evaluate the antihypertensive effect of candesartan cilexetil (Atacand™) in comparison to losartan.

New Terms or terms used in Sample Operative Reports:

blunt tip
Entree thoracoscopy trocar and cannula
Hasson open laparoscopy cannula
infusion
Mladick cannula (for liposuction)
Origin trocar
pyramidal tip trocar
Simple Suction Probe (cannula)
VersaPort trocar system

A collagen fragment that inhibits angiogenesis; currently being developed for a variety of anti-cancer applications.

Device for suturing a sling to Cooper's ligament through a transvaginal approach without the need for an abdominal incision.

A non-nucleoside reverse transcriptase inhibitor (NNRTI) in clinical trials for the treatment of HIV/AIDS. Mfg: Agouron Pharmaceuticals.

CAPRIE (clopidogrel versus aspirin in patients at risk of ischemic events) is a clinical study comparing the efficacy of new antiplatelet agent clopidogrel (see Plavix™) versus aspirin therapy as a treatment for the prevention of strokes.

Device designed for shrinking connective tissue of the lining of a joint (the capsule). See ArthroCare arthroscopic system and ArthroWand. Mfg: ArthroCare.

Applied following bone graft procedure to keep grafted bone or bone substitute (see Hapset) from migrating and to prevent unwanted tissue formation before the grafted material has had time to integrate and heal. Source: Lifecore Oral Restorative Division (manufacturer) via telephone.

An external continence device for the management of urinary leakage in women suffering from stress urinary incontinence. The CapSure shield is a noninvasive, patient-applied device which fits over the urinary meatus. Similar to applying a suction cup, air is squeezed out of the device's cap while the device is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. Approved by the FDA in 11/97 under the proprietary name "Restore (a.k.a. Capsure)," the product is currently marketed by C.R. Bard under the trademark name CapSure (shown on packaging as CapSure™) and is available by prescription only.

Steroid-eluting, bipolar, epicardial pacing lead indicated for use with a pulse generator as part of a cardiac pacing system where implantable epicardial, atrial or ventricular, single- or dual-chamber, pacing systems are indicated. Mfg: Medtronic.

Study at Columbia-Presbyterian CPMC.

Generic captopril tablets USP (generic equivalent to Capoten®) for treatment of hypertension, heart failure, and left systolic dysfunction after myocardial infarction. Available tablet doses: 12.5 mg, 25 mg, 50 mg and 100 mg. Mfg: Purepac Pharmaceutical Co. .

Blood screening test for the detection of syphilis in the serum or plasma of blood donors. Mfg: Immucor, Inc. .

A sustained-release (sprinkle capsule) formulation of the antiepileptic medication carbamazepine; permits a twice-a-day dosage regimen as opposed to the three or four doses per day of the immediate-release tablet form. Indications: for use as an anticonvulsant in patients with epilepsy; for the treatment of pain associated with trigeminal neuralgia. Distributed by Elan Corporation (Athena Neurosciences, Inc.)/Shire Pharmaceutical Group.

Generic version of Sinemet® CR tablets (DuPont Pharmaceuticals). Indicated for the treatment of symptoms associated with Parkinson disease; available in 50 mg/200 mg and 25 mg/100 mg strengths of carbidopa and levodopa. Mfg: Mylan Laboratories, Inc.

A water-insoluble form of iron produced by a chemical carbonyl decomposition process which renders it less toxic than ferrous forms of iron; used in dietary supplements and in the treatment of iron-deficiency anemia. See, for example, Icar™ product line and Nestabs® CBF.

Gelatin-sealed ascending aortic valved graft designed using Carbomedics® prosthetic heart valve and Vascutek® Gelweave graft. Mfg: Sulzer Medica.

For perfusion of the aorta during open chest procedures that require cardiopulmonary bypass (6 hours or less); the device eliminates the need for crossclamping. When inflated, the balloon isolates the myocardium and aortic root while allowing delivery of antegrade cardioplegia and venting of the aortic root. Mfg: Cardeon Corporation.

Indicated for use with the Cardiac STATus™ rapid format troponin I panel test to verify its performance. Mfg: Spectral Diagnostics Inc.

Point-of-care cardiac marker assay. Mfg: Spectral Diagnostics Inc.

For detection of myocardial cell necrosis; hand-held unit designed for use in point-of-care settings. Test uses whole blood, serum, or plasma and presents results within minutes. Mfg: Spectral Diagnostics Inc.

Rapid (results in 15 minutes), ultrasensitive test for detection of troponin T in the blood stream, a protein released during cardiac event indicating the degree of cardiac damage. Mfg: Roche (formerly Boehinger Mannheim).

A test to identify patients who have a genetic predisposition to salt-sensitive hypertension. The test points to a specific genetic variant, and clinical trials indicated that only patients with this variant benefited from a low-salt diet. Identification of this patient population would lead to more effective therapy, e.g., early dietary restrictions and closer monitoring, to prevent or reduce high blood pressure and associated risk of kidney failure, stroke, heart attack, or premature death. Mfg: Myriad Genetics, Inc..

Device consists of reusable electrodes and a pre-fitted chest electrode belt for outpatient electrocardiographic monitoring, capable of transmitting data to medical personnel for interpretation. Mfg: Miridian Medical Technologies.

Device indicated for airway gas analysis and ventilation measurement during surgical procedures and postanesthesia care. Device can be configured to add centralized monitoring and arrhythmia analysis. Mfg: Datex-Ohmeda.

Handheld, battery-operated exercise device for use as an adjunctive therapy to promote cardiovascular fitness and lower blood pressure with microprocessor-guided isometric exercise. Mfg: MD Systems, Inc..

Cardiac diagnostic tests for quantitative measurement of three cardiac-specific markers including CK-MB, myoglobulin and troponin I for assessment of cardiac injury. Mfg: Pace Corp.

See "Clinical Trial (Study) Acronyms"

Suite of software products that allows transtelephonic monitoring of patients with pacemaker implants and/or cardiac arrhythmias for remote management of patient information. Mfg: Instromedix..

A phytosterol in clinical trials for the treatment of primary hypercholesterolemia. Note: Manufacturer's web site and the majority of press releases employ all-caps form, CARDIOREX, when referring to this product; at least one Business Wire press release (05/27/97), however, shows the trademark name written as CardioRex. Mfg: Forbes Medi-Tech Inc.

Cardiac implant designed for repair and sealing of heart defects via minimally invasive, catheter-based delivery system. Under FDA approved humanitarian device exemptions (HDEs), device is being commercially distributed for the following indications: (1) Treatment of patients with complex single ventricle physiology who have undergone a fenestrated Fontan palliation procedure and require closure of the fenestration; (2) treatment of patients with complex ventricular septal defects (VSD) of a significant size to warrant closure, but that, based on location, cannot be closed with standard surgical transatrial or transarterial approaches; (3) treatment of patients with a patent foramen ovale (PFO) with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy. Clinical trials related to these and other indications continue. Mfg: NMT Medical, Inc.(formerly Nitinol Medical Technologies).

Electrocardiographic (ECG) information management software system for use with other Micromedical monitoring products. Mfg: Micromedical Industries Ltd. (Australia).

Infusion delivery system for Cardizem injectable; consists of a prefilled vial containing 100 mg of nonrefrigerated, lyophilized Cardizem integrated with a transfer set for use with 100 mL infusion bags. Indication: For treatment of atrial fibrillation or atrial flutter for up to 24 hours. Mfg: Aventis Pharmaceuticals (formerly Hoechst Marion Roussel).

A rapid immunoassay for the detection of infectious mononucleosis designed for use in hospital, physician office, or lab. Specimen: serum, plasma, or whole blood. Test results in approximately five minutes. Mfg: Quidel Corporation.

Rapid pregnancy test designed for use by clinical laboratories. Mfg: Quidel Corporation.

calcium antagonist in reperfusion trial.

carvedilol atherectomy restenosis trial.

CARE - cholesterol and recurrent events. Study investigating the potential benefits of lipid-lowering agents when used after acute myocardial infarction as prophylaxis against recurrent attacks. See Calgary-CARE.

Electronic amplifying stethoscope for monitoring a patient in a remote location via telephone lines. Mfg: American Telecare Inc.

A gel for the treatment of chronic wounds such as venostasis, diabetic and decubitus ulcers (pressure sores) and other wounds such as burns. U.S. clinical trials expected to begin in mid-1997. Developed by Life Medical Sciences, Inc./CHAI.

Randomized, double-blind, placebo-controlled trials of ranolazine used in combination with other antianginal drugs for the treatment of stable angina. CARISA is an acronym for combination assessment of ranolazine in stable angina.

An over-the-counter (OTC) topical preparation for the prevention and treatment of skin irritation associated with adult incontinence. Mfg: G&W Laboratories, Inc. (800-922-1038).

Cryoablative reduction of menstruation - A procedure for treatment of abnormal uterine bleeding (AUB). See FemRx Soprano™ cryotherapy system.

Tissue heart valve prosthesis designed for small heart valves without requirement for postoperative anticoagulation therapy. Mfg: Baxter.

Wound cleansing product for wound care management. Mfg: Carrington Laboratories, Inc.

A three-layer, self-adhesive, hydrophilic foam dressing designed for exudate management of venostasis ulcers, diabetic ulcers, pressure sores, partial-thickness and full-thickness wounds, first- and second-degree burns, abrasions, lacerations, and donor sites. Mfg: Carrington Laboratories, Inc.

Hydrogel wound care dressing for wound management. Mfg: Carrington Laboratories, Inc.

Investigational cancer therapy, with potential application in the treatment of major solid tumors, including melanoma, breast carcinoma, prostate carcinoma, colon carcinoma, hypernephroma and soft-tissue sarcoma. Mfg: Carrington Laboratories.

Dietary supplements, frozen and nonfrozen (NF) forms, which contain complexes extracted from shark cartilage. .

Indicated for ligation of bleeding vessels in the abdominal wall as well as other laparoscopic surgical applications; a component of the CloseSure™ procedure kit.

For the treatment of angina and hypertension. Cartia XT is the generic equivalent of Cardizem® CD (Aventis) and is available in 120-, 180-, 240-, and 300-mg extended-release capsules. Mfg: Andrx Pharmaceuticals.

This relates to a Swedish technique, now performed in the U.S., in which a patient's own cartilage cells are removed, grown, and then reimplanted to fill a cartilage defect of the knee. The orthopedist performs an arthroscopic procedure to remove cartilage cells from the injured part of the knee, usually the knee end of the thigh bone. The cells are sent to the Genzyme tissue repair laboratory (Carticel service) where they are grown for two to three weeks. In a second procedure, the regenerated cells are injected into the defective portion of the knee where they facilitate repair of damaged tissue. To keep the cells in place, a small flap of periosteal tissue from the lower portion of the leg is sutured over the cartilage defect and, at the surgeon's discretion, glued with fibrin glue for watertightness. Mfg: Genzyme.

A GNC trademark name for a line of OTC dietary supplements containing shark cartilage liquid extract. Developed and marketed by AEterna Laboratories Inc. as CarTCell® and CarTCell® NF; marketed by General Nutrition Companies (GNC) as Carticin™.

A natural antiangiogenesis factor for the treatment of solid tumors. As of April 1996, under development by Boston Life Sciences, Inc.

Casodex, one 50-mg tablet once daily, has been approved since 1995 for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analogue for the treatment of stage D2 metastatic carcinoma of the prostate. See monograph for additional information. Proposed additional indication: 150-mg monotherapy tablets for the treatment of locally advanced, nonmetastatic prostate cancer. Supplemental NDA (sNDA) submitted; approval pending FDA review.0.

Cardiac Arrhythmia Suppression Trial - Study of the efficacy of ventricular arrhythmia suppression with various drug protocols after a myocardial infarction. See Calgary-CAST.

Indicated for suturing and fixation.

New surgical device for cataract removal through a 1- to 2-mm hole created in the lens capsule. Device uses mechanical energy source with procedure taking less than 10 minutes. Not yet FDA approved.

Device designed for soft tissue reattachment and capsular repair of rotator cuff injuries, Bankart lesion, and SLAP lesion repair procedures. Mfg: DePuy OrthoTech.

New Terms or terms used in Sample Operative Reports:

AutoGuard™
AutoGuard-P™
Broviac
ChronoFlex®
Dobbhoff
double-lumen
Du Pen® epidural catheter
Embryon® GIFT catheter
Embryon® HSG (hysterosalpingography/hysterosonography) catheter
Flexxicon
Flexxicon Blue dialysis catheter
Flexxicon II PC internal jugular catheter
Foley
Foley three-way
Groshong central venous catheter
Hickman® catheter
Hohn® central venous catheter - single and double-lumen
HUMI uterine manipulator/catheter
Hurwitz dialysis catheter
InfusaSleeve II™ catheter
Insyte AutoGuard™ IV catheter
Insyte AutoGuard-P™ IV catheter
IVUS catheter (intravascular ultrasound)
Kaye tamponade balloon catheter
Leonard® catheter
Opti-Flow™ catheter (see Vas-Cath® Opti-Flow™)
PermCath®
Per-Q-Cath®
PIC
PICC
Port-A-Cath
PRO™ infusion catheter
red rubber catheter
Release-NF™
Soft Seal™ cervical catheter
Soft Torque™ uterine catheter
Soft-Cell™ catheter (see Vas-Cath® Soft-Cell™)
Spectranetics support catheter
support catheter
Tenckhoff™ peritoneal dialysis catheter(s)
TFX Medical catheter stylet
triple-lumen
T-TAC (transcervical tubal access catheter) system
Vas-Cath®
Vas-Cath® Opti-Flow™ long-term dual-lumen hemodialysis catheter
Vas-Cath® Soft-Cell™ permanent dual-lumen hemodialysis catheter
V-Cath Dual Lumen PICC E.S.P. catheter
Zynergy Zolution electrophysiology catheter

Vascular access devices for administration of medications, IV fluids, blood and parenteral products. Mfg/Source: Bard.

Portable system for locating catheter tip during implantation of vascular access devices in place of fluoroscopy. Mfg/Source: Bard.

Spring-guide catheter indicated for the administration of local anesthetics into the epidural space for pain management; this catheter is longer to accommodate additional threading that may be necessary due to scar tissue or abnormal anatomy.

Maps and locates the cavernosal nerve filaments to aid the surgeon in preserving and sparing these nerve bundles (when feasible) in an attempt to maintain patient potency and continence. Previously FDA approved for use during prostatectomy procedures and now approved for use during colorectal surgery on men. Mfg: UroMed.

See Cooksey-Cawthorne exercises.

An orally administered steroid in phase III clinical trials for the treatment of idiopathic thrombocytopenic purpura (ITP). Additionally, the manufacturer has requested an orphan drug designation for this indication. Mfg: InKine Pharmaceutical.

A multicenter study to compare Serzone® (nefazodone HCl) to a modified form of psychotherapy specifically designed for chronically depressed patients. The study will employ three approaches to treatment of patients with chronic major depression and double depression: pharmacotherapy, Serzone; psychotherapy, Cognitive Behavior Therapy for the Chronic Depressions (CBT-CD); Serzone and CBT-CD combined. Study sponsored by Bristol-Myers Squibb, the manufacturer of Serzone.

See ganaxolone (CCD 1042).

See Canadian Cardiovascular Society classification (CCSC).

Related to evaluation of the severity of unstable angina. Classification is based on activity evoking angina/limits to normal activity:

class I - prolonged activity/no limits

class II - walking more than two blocks/slight limits

class III - walking less than two blocks/marked limits

class IV - minimal activity or rest/severe limits to normal activity.

On dictation, patients may be noted to have a CCSAS (Canadian Cardiovascular Society angina score) of I, II, III, or IV.

Irrigation system. Mfg/Source: Bristol-Myers Squibb/ConvaTec.

Dental system provides high-resolution, panoramic radiographs without film. Mfg: Schick Technologies, Inc.

A rapid diagnostic test to detect toxin A of Clostridium difficile (C. difficile), a common cause of diarrhea and colitis in patients recently treated with antibiotics. Mfg: BioStar Inc., div. of Thermo BioAnalysis Corporation.

A yttrium-90-radiolabeled therapeutic agent designated an orphan drug for the treatment of small cell lung cancer (SCLC) [10/98], pancreatic cancer [12/98], and ovarian cancer [8/99]. Clinical trials for tumor targeting and treatment with CEA-Cide continue in patients with colorectal, pancreatic, medullary thyroid, and metastatic breast and ovarian cancers. Note: CEA is an acronym for carcinoembryonic antigen; CEA-Cide is a humanized monoclonal antibody against carcinoembryonic antigen, which is expressed by a variety of solid tumors. Mfg: Immunomedics, Inc.

A broad-spectrum cephalosporin antibiotic for the treatment of acute bacterial otitis media, acute bacterial exacerbation of chronic bronchitis, and pharyngitis/tonsillitis. Once-daily dosing; available in 400-mg capsules for adults and in 9 mg/kg a day oral suspension for children. See Medical Sciences Bulletin, April 1996. Mfg: Schering-Plough Corporation.

A 128-channel electroencephalography (EEG) system for monitoring of neurological disorders. Mfg: Bio-logic Systems - 847-949-5200.

A foldable intraocular lens for use in cataract surgery. Only a small incision is required with a less invasive implantation procedure and shorter recovery time. Mfg: Pharmacia & Upjohn.

Heparin surface-modified intraocular lens indicated for the prevention of cellular deposits following lens implantation. Mfg: Pharmacia & Upjohn.

Generic equivalent to Duricef® (Bristol-Myers Squibb). A broad-spectrum antibiotic indicated for the treatment of urinary tract infections, skin infections, pharyngitis, and tonsillitis; available in 1-g tablets and 500-mg capsules. Mfg: IVAX.

Indicated for the treatment of early Lyme disease. Recommended dosage: 500 mg b.i.d. x 20 days. See Ceftin provided by DrugInfoNet. Mfg: Glaxo Wellcome.

Former trademark name; see Celebrex™.

A COX-2 inhibitor approved for the treatment of rheumatoid arthritis and osteoarthritis. Also approved as an adjunct to conventional care—endoscopic surveillance, surgery—in the treatment of patients with familial adenomatous polyposis (FAP) to reduce the number of adenomatous colorectal polyps. Research is also being conducted regarding the use of Celebrex in the treatment of sporadic adenomatous polyps (SAP) of the colon, Barrett esophagus, actinic keratosis, and superficial bladder cancer. Recommended dosage/administration: for rheumatoid arthritis, 100 mg to 200 mg twice daily; for osteoarthritis, 200 mg daily either as a single dose or 100 mg twice daily; for FAP, 400 mg twice daily. Available in 100- and 200-mg capsules. Note: Previously trademarked as Celebra; however, the brand name has been changed to Celebrex to avoid possible confusion with another unrelated trademark name drug. Jointly marketed by G.D. Searle & Co. and Pfizer Inc.

An SSRI for the treatment of depression. Available in 20- and 40-mg tablets; a peppermint-flavored oral solution, 10 mg/5 mL, was approved on 12/29/99. See product monograph for additional information. Mfg/marketed by: Forest Laboratories and Parke-Davis, a div. of Warner-Lambert.

Point-of-care test for monitoring of clotting time. Test is performed on 2 or 3 drops of blood with results available in approximately two minutes. Note: Although Celite® is a registered trademark of Celite Corporation, the manufacturer's site shows this test as "celite" (lowercase and superscript) and also as celiteACT. Mfg: i-STAT Corporation.

An OTC dietary supplement said to help reduce cellulite. Mfg: Medestea International (Italy); distributed in the U.S. by Rexall Sundown, Inc.

Indication: use in combination with cyclosporine and corticosteroids to prevent organ rejection in patients undergoing allogenic kidney, heart, or liver transplantation. Expanded indication to include liver transplant patients approved by the FDA 8/4/00. CellCept is available in 250-mg capsules and 500-mg tablets; see monograph for specifics related to dosage and administration. Also see CellCept intravenous and CellCept oral suspension. Mfg: Hoffman-La Roche.

Indication: use in combination with cyclosporine and corticosteroids to prevent organ rejection in patients undergoing allogenic kidney, heart, or liver transplantation. Expanded indication to include liver transplant patients approved by the FDA 8/4/00. See monograph for specifics related to dosage and administration. Also see CellCept capsules/tablets and CellCept oral suspension. Mfg: Hoffman-La Roche.

Indication: use in combination with cyclosporine and corticosteroids to prevent organ rejection in patients undergoing allogenic kidney, heart, or liver transplantation. Expanded indication to include liver transplant patients approved by the FDA 8/4/00. See monograph for specifics related to dosage and administration. Also see CellCept tablets/capsules and CellCept intravenous. Mfg: Hoffman-La Roche.

Cystoscopic, minimally invasive, brush-biopsy system used to obtain cell samples for analysis and diagnosis of bladder cancer. Mfg: Medical Device Technologies.

See Haemonetics™ Cell Saver 5.

Viscoelastic solution for use in the anterior segment of the eye; indicated to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery. Mfg: Alcon Laboratories, Inc.

A standardized flush and cold storage solution for preservation of donor organs—heart, kidney, liver, pancreas—prior to transplantation. Mfg: SangStat.

Temperature-sensing ablation catheter. Product detail. Mfg: Biosense Webster.

A plant-derived synthetic conjugated estrogens product for the treatment of moderate to severe vasomotor symptoms associated with menopause. Available by prescription only in dosage strengths of 0.625 mg, 0.9 mg, and 1.25 mg. See product monograph. Note: The 1.25-mg tablet was recently FDA approved; approval of a 0.3-mg tablet is pending FDA review. Clinical trials will be initiated this year to support an osteoporosis indication. Mfg: Duramed Pharmaceuticals; jointly marketed by Duramed Pharmaceuticals and Solvay Pharmaceuticals, Inc.

Dental laser designed for hard-tissue procedures, including dental caries, cavity preparation, and other applications previously accomplished with a high-speed drill; approved for pedodontic (patients under 18) use. Mfg: Premier Laser Systems (800-544-8044).

Defect as possible side-effect from laser surgery that causes distorted images and reduction in visual acuity, treatable with repeat laser photoablation.

An in vitro diagnostic (IVD) indicated as an adjunct to standard cytogenetic analysis, used to identify and enumerate chromosome 12 in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B cell chronic lymphocytic leukemia. Mfg: Vysis, Inc.

In vitro diagnostic (IVD) device using FISH technology for identification of abnormal chromosomes in bone marrow samples of patients with CML (chronic myelogenous leukemia), AML (acute myeloid leukemia), myeloproliferative disorder, myelodysplastic syndrome as well as other hematologic disorders. Mfg: Vysis.

Cell-separation device with improved software features; previously approved to select progenitor cells from bone marrow, awaiting FDA approval to include selection of peripheral blood progenitor cells and tumor purging. See CEPRATE® TCD T-cell depletion system. Mfg: CellPro.

Device is designed to reduce T-lymphocytes in peripheral blood stem cells prior to allogeneic transplantation. Removal of these cells should reduce the incidence of graft-versus-host disease (GVHD) side effect, an immunologic reaction often developed by donor recipients. CEPRATE® TCD will begin clinical trials in conjunction with CellPro's already approved CEPRATE® SC (stem cell) concentration system. Mfg: CellPro.

An in vitro diagnostic (IVD) DNA probe kit utilizing FISH technology for assessing the ratios of XX and XY cells of bone marrow specimens in patients who have received opposite sex (sex-mismatched) bone marrow transplants for treatment of leukemia or myeloid disorders. Mfg: Vysis.

An in vitro diagnostic (IVD) DNA probe kit utilizing FISH technology for assessing the ratios of XX and XY cells of bone marrow specimens in patients who have received opposite sex (sex-mismatched) bone marrow transplants for treatment of leukemia or myeloid disorders.

CerAxon™ (citicoline sodium)

Investigational drug for the treatment of patients with ischemic stroke. Unlike earlier clinical trials, the most recent trials failed to demonstrate reduction in infarct size or improvement in neurological function in ischemic stroke patients on a 500 mg/day dose of CerAxon. In April 1998, a previously submitted NDA was withdrawn and additional trials involving a larger patient population were initiated. Preliminary analysis of the double-blind, placebo-controlled trials, ECCO 2000 (effects of citicoline on clinical outcome - 2000 mg), indicated that while some secondary endpoints were positive, the primary endpoint was not met. A decision regarding future U.S. development of citicoline is pending. Mfg: Interneuron Pharmaceuticals, Inc.

Procedure for diagnostic in vitro analysis of cerebrospinal fluid. CSF procedure software will be added to the Micro21 system, which will now have seven laboratory applications, including WBC differential analysis and morphology, RBC morphology, platelet estimates, reticulocyte count, ANA and nDNA analysis and now CSF. Mfg: Intelligent Medical Imaging (561-627-0344 or 212-661-8030).

New intravenous antiepileptic drug for acute treatment of status epilepticus (nonstop uncontrolled seizures). Cerebyx will gradually replace IV Dilantin (phenytoin).

Indications: (1) daily multivitamin maintenance dosage for adults and children 11 years and above receiving parenteral nutrition; (2) situations where the administration by the intravenous route is required, e.g., surgery, extensive burns, fractures and other trauma, severe infectious diseases, comatose states, etc. Mfg: Baxter Healthcare.

An investigational cytoprotective drug for the prevention of central nervous system ischemia. Ceresine, a small molecule drug, reduces the accumulation of lactic acid in the brain that occurs after head injury or stroke. It is currently in phase III clinical trials in patients with closed head injury and in phase II trials related to the treatment of stroke patients and the treatment of pediatric patients suffering from congenital lactic acidosis. Orphan drug designation for use in patients with severe brain injury has been granted by the FDA. Mfg: Questcor Pharmaceuticals, Inc. (formerly Cypros Pharmaceutical Corp.).

Technetium 99m (Tc-99m) contrast imaging agent commonly used with SPECT (single photon emission-computed tomographic) imaging to detect cerebrovascular accidents. Trials are currently being conducted and look promising for the use of Ceretec® to help diagnose Alzheimer disease. Mfg: Nycomed Amersham.

DTaP (diphtheria and tetanus toxoids with acellular pertussis) vaccine. Indication: active immunization against diphtheria, tetanus, and pertussis in children age six weeks to seven years. Mfg: North American Vaccine, Inc.; marketed by Ross Products Division of Abbott Laboratories Inc.

Colposcope for visualization of the vagina and cervix, which utilizes digital imaging and provides software analysis, measurement of any lesions, and documentation of any cervical changes. Mfg: CooperSurgical.

Bone-growth stimulator, similar to a cervical collar with a battery-operated microprocessor, uses a pulsed, low-energy, electromagnetic field (PEMF) to increase success rates in patients at high risk for failure of cervical fusions (smokers and patients who have undergone multiple fusion procedures). Mfg: Orthofix.

A luteinizing hormone-releasing hormone (LHRH) antagonist. Indication: inhibition of premature LH surges in women undergoing controlled ovarian stimulation. See product monograph for additional information. Mfg: Asta Medica (Germany)/Muro Pharmaceutical, Inc.

An implantable device for testing of body fluid collected subcutaneously. The system, for use in measuring blood glucose levels in diabetic surgical patients, is comprised of a capillary filtrate collector (CFC), a device which collects body fluid subcutaneously, and a filtrate bioscanner that measures glucose levels in the ultrafiltrate collected via the CFC. Testing of the device in hospitalized patients is to begin following FDA approval of an IDE (investigational device exemption). Mfg: Polymer Technology Systems.

System for detection and measurement of T-wave alternans in order to identify patients at increased risk for sudden cardiac death.

See Paragon™ Champion™ stent system.

Catheter-based system for treatment of in-stent stenosis, a complication associated with coronary artery disease. The closed-end, noncentering catheter delivers a 0.030-inch-diameter ribbon of 6, 10, or 14 iridium-192 seeds to the blockage. PMA has been recommended for approval; final approval awaiting FDA review. Mfg: Cordis Corporation, a Johnson & Johnson company.

Ongoing clinical trials comparing the antiviral efficacy of Hoffmann-La Roche's Fortovase™ (saquinavir, soft-gel formulation) to Merck's Crixivan® (indinavir) using one or the other in combination with other antiretroviral drugs in treating HIV/AIDS patients. CHEESE: comparative trial of HIV-infected patients evaluating efficacy and safety of saquinavir-enhanced oral formulation and indinavir given as part of a triple drug therapy.

A computer-based information and support system to help patients with breast cancer and other serious diseases understand their diagnosis and treatment options, make decisions regarding treatment, and cope with those decisions thereafter.

System combines microwave heating with a balloon catheter to shrink obstructing prostatic tissue and create a natural biological stent for maintaining patency. FDA approved to begin clinical trials. Mfg: Cheung Laboratories, Inc.

Echogenic point allows for enhanced ultrasound imaging. Source: ASSI product list.

OTC; specifically formulated allergy medication for children. Mfg: McNeil Consumer Products division of Johnson & Johnson.

OTC; specifically formulated to treat sinus infection in children. Mfg: McNeil Consumer Products division of Johnson & Johnson.

Component of the Chilli cooled ablation system delivers cooling fluid to prevent excessive heating of the electrode tip during ablation procedures for treatment of ventricular tachycardia. Not FDA approved. Mfg: Cardiac Pathways.

Catheter ablation system uses radiofrequency (RF) energy for treatment of ventricular tachycardia by creating deep lesions in ventricular scar tissue. System consists of the Chilli® catheter and the Model 8004 RF generator. Not FDA approved. Mfg: Cardiac Pathways.

OTC product designed to stop nocturnal mouth breathing and associated snoring. Mfg: Chin-Up Company.

A local, long-acting anesthetic for use in a wide range of surgical procedures, for pain relief during childbirth, and for pain management following surgery. Developed by Celltech Chiroscience; marketed in the U.S. by Purdue Pharma.

Preoperative patient skin preparation; contains chlorhexidine gluconate 2% (w/v) and isopropyl alcohol 70% (v/v). Mfg: Medi-Flex Hospital Products, Inc. (913-451-0880). Source: FDA approvals - 07/14/00.

Former trademark names; see Welchol™.

Cholestech L.D.X.® system

Portable, multi-test, diagnostic system which returns results in five minutes from a single drop of blood. FDA approved for additional panel of renal tests for identifying kidney disorders. .

Over-the-counter self-test system for measuring total cholesterol; results are provided within 15 minutes.

Hand-held diagnostic device for measurement of cholesterol levels with results available in minutes. Not FDA approved. Mfg: Lifestream Technologies.

Hand-held diagnostic device for measurement of cholesterol levels with results available in minutes; indicated for use in the professional setting. Mfg: Lifestream Technologies.

An engineered autologous tissue-based product in phase III clinical trials for the treatment of vesicoureteral reflux.

System indicated for repair of chondral defects of the articular cartilage. A paste consisting of a mixture of the patient's cancellous bone and articular cartilage is used as an anatomic patch for repair of the defect with a supportive matrix used to promote new cartilage formation.

Technique for performance of endoscopic carpal ligament release through an open-slotted cannula, performed under local anesthesia without a tourniquet; developed by Dr. James C. Chow.

Intelligent microscopy system screens blood samples for diagnosis of malignancies and infections by identifying specific cells through digital color characteristics produced by reaction of diagnostic stains with the cells. Applications include screening for prenatal Down syndrome, HIV, chronic leukemia and cancer detection. Mfg: ChromaVision Medical.

Polyurethane open-ended catheter. Mfg/Source: Bard.

A tissue-repair synthetic peptide in clinical trials as a topical treatment for diabetic ulcers; additional trials are planned to evaluate its effectiveness in accelerating healing of other chronic wounds and surgical incisions. Other possible indications include the use of Chrysalin in injectable form for the prevention of vascular occlusion (restenosis) following balloon angioplasty and stenting procedures. In addition, preclinical trials of Chrysalin demonstrated the potential to accelerate the healing process in fresh bone fractures, and further development for this indication is being pursued by OrthoLogic Corporation under a licence agreement with Chrysalis BioTechnology. Mfg: Chrysalis BioTechnology.

Over-the-wire percutaneous tracheostomy introducer set for dilation and placement of a tracheostomy tube.

Adhesive topical gel sheeting indicated for the management of hypertrophic and keloid scars and lessen the overall effect of scarring following surgery. Note: This product was previously manufactured as Silastic®. Mfg: Smith & Nephew Wound Care

An investigational lipopeptide antibiotic found to be effective against gram-positive bacterial pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). Currently in clinical trials (EDGE™) for the treatment of community-acquired pneumonia, complicated urinary tract infections, and skin and soft tissue infections. EDGE is an acronym for evaluation of daptomycin in gram-positive entities. Mfg: Cubist Pharmaceuticals, Inc.

A cigarette containing TSNA-free tobacco to be prescribed and used in a smoking-cessation program under a physician's supervision. Currently in clinical trials pursuant to an IND filed with the FDA. Note: Press release uses all-caps convention, CIGRX™, when referring to this product. Licensee: Star Tobacco & Pharmaceuticals, Inc.

Antiplatelet and vasodilator drug in clinical trials to determine its effectiveness in the treatment of severe intermittent claudication secondary to peripheral vascular disease. See cilostazol and Jobst projects.

Both intravenous and tablet forms of Cipro, in combination with metronidazole, have been approved for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
New indication: treatment of mild to moderate acute sinusitis with recommended adult dose of 500 mg every 12 hours for 10 days.
New formulation: Oral suspension formulation for the treatment of acute sinusitis, acute exacerbation of chronic bronchitis, urinary tract infection, acute uncomplicated cystitis in females, chronic bacterial prostatitis, complicated intra-abdominal infection, skin and skin structure infection, bone and joint infection, infectious diarrhea, typhoid fever, and uncomplicated and urethral gonorrhea. Formerly available in tablet and IV forms. By prescription only; dosage dependent on indication. Mfg: Bayer.

Adjustable (interlocking bands), nonelastic garments for compression therapy and venous ulcer treatment; available by prescription only. The following CircAid products are indicated for use in patients with venous insufficiency and lymphedema: Quick-Fit™ Thigh-High legging; Ready-Fit™ `96 legging; Precision-Fit™ legging, which accommodates unusual shape, abnormal size or length of leg; Quick-Fit™ thigh-high legging. These products come with Quick-Fit™ Ankle-Foot™ wrap, which covers the ankle and foot area completely and augments the legging. Also available are CircAid® leggings with extended Zipper-Fit™ for patients who require additional ease of application. Indicated for use in patients with venous insufficiency: CircPlus™ with Ankle-Foot™ wrap to reduce and contain edema and prevent ulcer recurrence; Thera-Boot™. Indicated in patients with lymphedema: Quick-Fit™ Arm-Sleeve. All products are contraindicated in patients with severe arterial insufficiency and/or acute infection.

An end-diastolic pneumatic compression device connected to an EKG QRS monitor that times the compression cycle to occur after an operator-selectable variable delay following the QRS signal. The Circulator boot system may be used alone or in combination with other drug or device therapies to treat peripheral arterial disease, ischemic lesions, claudication pain, necrotizing cellulitis, venostasis ulcers, stasis dermatitis, chronic lymphedema, and thrombophelbitis. Mfg: Circulator Boot Corp. (610-896-6545).

For treatment of venous ulcers. Mfg: ConvaTec.

For use in hysteroscopic procedures utilizing safer isotonic fluids, compared to present usage of hypotonic fluids, which (if absorbed) can cause serious complications, including death. Mfg: Microgyn.

See CerAxon™.

New Terms or terms used in Sample Operative Reports:

Adair
Allis
Babcock
Heaney
Kelly
Kocher
Sweetheart

Implant which bypasses ear damage sending electric signals directly to the auditory nerve. These signals are then interpreted by the brain as sounds.

A new component of the Clarion® cochlear implant system indicated for use in postlingually deafened adults. The electrode is surgically positioned in the cochlea using the positioner (Electrode Positioning System™). Mfg: Advanced Bionics.

Claritin (10 mg loratadine) in a rapidly-disintegrating tablet which dissolves almost instantly in the mouth. This utilizes a new drug delivery technology known as the Zydis® delivery system, which does not require water, thus making the drug easy to take and available whenever needed. Indicated for relief of allergy symptoms and available by prescription only for administration to adults and children as young as 6 years of age. Product launch is scheduled for March 1997. Other Claritin products include Claritin-D 12 Hour (5 mg loratadine, 120 mg pseudoephedrine sulfate), Claritin-D 24 Hour (10 mg loratadine, 240 mg pseudoephedrine), and Claritin syrup (loratadine 10 mg per ml). Mfg: Schering-Plough Corporation.

Indicated for dissecting and tunneling during deep pelvic surgery.

A commonly used biological model to estimate a woman's risk of developing breast cancer. The Claus model determines risk based on the number of her first- and second-degree relatives with breast cancer and their ages of onset.

One-piece connector prevents backflow when intravenous line is disconnected. Mfg: ICU Medical.

Fiberoptic light, smoke plume evacuator, cutting and coagulation all-in-one instrument.

OTC transparent nicotine patch to assist in smoking cessation. Mfg: SmithKline Beecham.

Radiopaque device for use in coronary artery bypass grafting (CABG) procedures; used to temporarily shunt blood around the arteriotomy anastomosis site during surgery. Mfg: Medtronic.

An investigational anti-CD4 immunotherapeutic in clinical trials for the treatment of rheumatoid arthritis. Consideration is being given to future deners in development: IDEC Pharmaceuticals Corporation and SmithKline Beecham.

Three-day treatment option has been approved for nonpregnant women with bacterial vaginosis. Indication for the seven-day treatment option has been expanded to include the treatment of bacterial vaginosis in pregnant women in their third trimester. New packaging for the three-day treatment will include a 21-gram tube with three disposable applicators. Packaging for the seven-day treatment, a 40-gram tube with seven applicators, remains unchanged. Mfg: Pharmacia & Upjohn.

Solid, oval-shaped suppositories indicated as a once-daily, three-day treatment for bacterial vaginosis in nonpregnant women. Mfg: Pharmacia & Upjohn.

Components of the Synthes USS (universal spinal system). The variable-axis components are composed of titanium and include rods, a transconnector system, pedical screws, back-opening 3D heads, and locking cap. Mfg: Synthes USA (610-647-9700).

A once-a-week transdermal estrogen replacement therapy (ERT) patch. New indication: use in the prevention of osteoporosis. The new indication applies to all current dosage strengths--0.05 mg, 0.075 mg, 0.01 mg--as well as the most recently approved 0.025-mg patch. Previously approved indications: treatment of vasomotor menopausal symptoms, vulval and vaginal atrophy, and hypoestrogenism. Mfg: Berlex Laboratories.

Generic bioequivalent to Cleocin T® topical solution 1% (Pharmacia & Upjohn) for topical antibiotic treatment of acne vulgaris. Mfg: Morton Grove Pharmaceuticals.

Preclinical - Product development begins with the identification of promising compounds and concepts that are scientifically challenging and may fill unmet medical needs. Extensive testing is then done in laboratory settings to assess the usefulness of the candidate therapies and to ensure that these novel approaches are safe to administer in humans. The resulting scientific data are then compiled and a formal request made to the FDA for permission to advance to the next phase of research and to administer the new drug to patients. This request is called an Investigational New Drug application, or an IND. Approval of the IND is given only after the scientific and ethical merits of the supporting research and the proposed phase I study have been evaluated in depth and experts concur with the company’s recommendation to move forward.

Phase I - Phase I studies are principally designed to examine the safety of a new medication and to begin to understand how the drug will work in humans through the gathering of extensive information to evaluate how the human body responds. Observations of how the medication is absorbed, distributed, metabolized and eliminated from the body are often made, along with assessments of how quickly a therapeutic concentration is achieved, how long the drug remains in the body, and what, if any, the effect drug metabolite by-products may have. With step-by-step increases in dose, the optimal dosage is eventually determined where minimum side effects are coupled with maximum therapeutic effect, termed the toxic-therapeutic window.

Many phase I studies enroll only healthy individuals to evaluate how a new drug behaves in humans. In some instances, the FDA and investigating physicians deem it more appropriate for phase I trials to enroll patients who suffer from the same disease that the new drug seeks to treat, rather than to study healthy volunteers. Candidates are enrolled in a study only after a review of their history and physical confirms their eligibility and an informed consent for treatment is given.

The number of patients enrolled in a phase I trial will vary depending on the step-wise progression established for achieving optimal dosing as well as prior clinical experience with similar compounds and approaches. As well, the FDA will recommend the required follow-up period for each study subject. Followup time periods may range from just a few days to six or more months. Further trials may continue only if phase I results indicate that the new therapy is reasonably safe in humans, and the FDA approves further investigations.

Phase II - Phase II studies are principally designed to evaluate the therapeutic effect of a new drug in patients who suffer from the targeted disease, and to confirm the safety profile established in earlier phase I trials. Second phase studies are sometimes placebo-controlled and often double-blinded where neither the patient or the medical personnel know if a placebo or the medication is being prescribed. Phase II trials tend to enroll a larger number of patients than in phase I and patient followup may be for longer periods. Phase II studies are tailored to specific treatment indications for which the company plans to seek broader approval. Phase II trials set the stage, and further establish parameters for, the longer-term phase III trials.

Recent reforms have been made to FDA procedures for clearing new drugs aimed at treating fatal diseases such as AIDS and cancer. In selected circumstances, and where compelling scientific evidence is presented, the FDA has indicated that it will expedite review of a company’s application for market clearance. Expedited review of phase II clinical data, and clearance of that early application, can obviate requirements for phase III trials.

Phase III - Phase III trials are principally designed to demonstrate the potential advantages of the new therapy over other therapies that are already on the market. Safety and efficacy of the new therapy are studied over a longer period of time and in many more patients enrolled into the study with less restrictive eligibility criteria. The scope of phase III studies is intended to help scientists identify rarer side effects of treatment and to prepare for a broader application of the product.

Silicone gel-filled cushions applied to surgical scars and scars related to other skin trauma (keloids, cuts, and burns) to improve appearance and provide comfort to the area. Approved for the OTC market. Note: Some press releases use all-caps form, CLINICEL. Mfg: Life Medical Sciences Inc.

Injection; for use as a source of calories and protein in patients where (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption is impaired, or (3) metabolic requirements for protein are substantially increased. Mfg: Baxter Healthcare Corp.

Topical gel formulation of clonidine for site-specific treatment of neuropathic pain. Currently in phase III trials in patients with peripheral neuropathic pain, painful diabetic neuropathy, and postherpetic neuralgia. Mfg: Curatek Pharmaceuticals (847-229-5920).

See Plavix™ and CAPRIE study.

See VNUS Closure® catheter/radiofrequency generator.

Indicated for full-thickness closure of trocar wounds; kit includes the Pilot™ suturing guide and the Carter-Thomason® suture passer.

Device is designed to remove clots from dialysis access sites by breaking down the clot to liquid form. Mfg: Microvena Corp.

A diagnostic test performed during the course of a gastric biopsy to detect the presence of Helicobacter pylori. The "CLO" in the product name is an acronym for Campylobacter-like organism. Campylobacter pylori is now known as Helicobacter pylori. Other products: Quick-Tap™ paracentesis tray and PYtest® (C-14 urea).

Tri-Med products CLOtemp™ (a CLOtest warming device), Quick In™ lubricating gel, and Quick Ease™ lubricating gel are no longer being manufactured.

See CytoGam®

A nucleoside analogue that functions as a non-nucleoside reverse transcriptase inhibitor in the treatment of HIV infection and AIDS. Currently in phase II/III clinical trials in Europe, Africa, and the United States. Mfg: Triangle Pharmaceuticals, Inc.

Battery-operated self-testing system for monitoring prothrombin time to ensure therapeutic levels in patients on anticoagulation therapy (i.e. Coumadin). Blood sample is taken via fingerstick with blood sample dropped on a test strip. Results are displayed within two minutes and given as an INR (International Normalized Ratio) value. Mfg: Roche (formerly Boehinger Mannheim).

An adeno-associated virus (AAV) based gene therapy currently in early clinical trials for the treatment of hemophilia B. Mfg: Avigen Inc.

Electrode/loop system indicated for resection, ablation, and fulguration of the prostate gland and bladder. Mfg: American Medical Systems.

Focused radiation therapy system for noninvasive stereotactic treatment of cancer tumors. Developed by Nova Therapeutic under the name Cobalt Scalpel, the device will be marketed by Universal Medical under the brand name Cobalt Knife. Mfg: Universal Medical Systems (813-535-2022).

Automated blood-collection system collects combinations of red blood cell (RBC), platelet, and plasma components from a single donation.

Surgical system based on Coblation® technology for use in neurosurgical procedures. Components include the DisCoblator™, Access™, and Versitor™ SpineWands™. Previously CE Mark approved; recently FDA approved. Mfg: ArthroCare in marketing alliance with Integra LifeSciences Holding Corporation.

Minimally invasive surgical procedure uses the ENTec® surgery system (ESS), the ReFlex™ wand, and Coblation® technology to treat snoring. Update: Approved for the treatment of enlarged turbinates and submucosal tissue shrinkage. Mfg: ArthroCare.

Patented "cold ablation" technology that disintegrates targeted tissue molecule by molecule with minimal damage to surrounding healthy tissue. See CAPS ArthroWand and ArthroWand.

With ratchet. Source: American Medical.

Investigational vaccine for the treatment of cocaine addiction in phase I clinical trials. The vaccine consists of a cocaine-protein conjugate which is expected to induce an anticocaine antibody response, thus reducing entry of cocaine into the brain and reducing the psychopharmacologic effect of the drug. Mfg: Cantab Pharmaceuticals (Cambridge, England).

Used to calculate renal function in adults age 20 and over by estimating creatinine clearance from serum creatinine. Note: Some printed references and spellcheck programs suggest "Cockroft" as the correct spelling; however, Cockcroft is correct according to journal articles authored by the developers. Ref: Cockcroft DW, Gault MH, "Prediction of creatinine clearance from serum creatinine," Nephron 1976;16(1):31-41; Gault MH, Cockcroft DW, "Creatinine clearance and age" (letter), Lancet 1975 Sep 27;2(7935):612-613 [via PubMed].

Cardiac stabilizer for retraction and stabilization of the heart during minimally invasive beating heart surgical procedures.

Indication: treatment of mild to moderate ulcerative colitis. Mfg: Salix Pharmaceuticals, Ltd.

Note: Former U.S. trademark name, BalAsa®; marketed outside the U.S. as Colazide® (U.K.), Colazid®, and Premid®.

Marketed in the U.S. as Colazal™.

A lozenge sold OTC to reduce the duration and the severity of symptoms associated with the common cold. Contains 11.5 mg zinc gluconate, glycine, corn syrup, sucrose, and natural flavors. Dose: One lozenge, completely dissolved in the mouth, q. 1-2h; maximum six lozenges per day; avoid citrus juices for one-half hour before and after taking lozenge. Note: Packaging shows name in all capital letters, COLD-EEZE. See Cold-Eeze FAQ.

Same product as Cold-Eeze but with 14.5 mg of zinc gluconate per lozenge and available only through special venues such as home shopping channels on cable. Indication, prohibition regarding citrus juices, and dosing information as above.

Component of the ENTec Surgery System (ESS) indicated for shrinking collagen of the mucosal surface of the nasal and oral cavities.

Foldable intraocular lens (IOL) for use after cataract extraction; used for correction between -4 and +33 diopters. Mfg: STAAR Surgical Company.

Triple-lumen model of the Colleague product line for simultaneous administration of medications and fluids. Mfg: Baxter Healthcare Corporation.

For use in ophthalmic surgical procedures.

Autotransfusion system designed for intraoperative and postoperative autotransfusion by continuously collecting, filtering and reinfusion of the patient's own salvaged blood.

An investigational oral formulation of collagen for the treatment of rheumatoid arthritis. Entering phase III clinical trials. Update: Due to disappointing results of phase III clinical trials, AutoImmune has stopped further development of this product for pharmaceutical applications. Mfg: AutoImmune, Inc.

Home test for occult blood in the stool. Biodegradable pad will turn blue and/or green if guaiac positive. Pad is floated in toilet after a bowel movement. Positive blood in the stool may indicate colorectal cancer.

Brand name generic alternative to Cortenema™ (Solvay Pharmaceuticals) for adjunctive therapy in the treatment of ulcerative colitis. Mfg: Paddock Laboratories, Inc.

Transcutaneous bilirubinometer for noninvasive, pain-free monitoring of bilirubin in newborns with jaundice. Mfg: Chromatics Color Sciences International, Inc. - 212-717-6544.

A rapid, single-step, point-of-care, rectal mucus test to screen for colorectal cancer; currently in late-stage clinical trials. Note: Mfg: Procyon BioPharma.

Eyeglass lenses indicated to improve color vision in patients suffering from color blindness or color deficiency. Available by prescription in two series: Deutan series, types 1, 2, 3, 4, and 5; Protan series, types 1, 2, 3, 4, and 5. Mfg: ColorMax Technologies, Inc.

Investigational autologous cell vaccine for the treatment of colorectal cancer.

Absorbent cover dressing. See ConvaTec.

Lymph node-specific MRI contrast agent. FDA approvable letter received for lymph node imaging; however, the FDA found the contrast agent to not be approvable at this time for use in the imaging of the liver and spleen. Mfg: Advanced Magnetics, Inc.

Indication (for women with intact uterus): treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. The patch is available in two dosage strengths: estradiol/norethindrone acetate 0.05/0.14 mg per day and 0.05/0.25 mg per day. Note: Product is marketed in Europe as Estalis™. Mfg: Noven Pharmaceuticals, Inc.; marketed by Aventis Pharmaceuticals (formerly Rhone-Poulenc Rorer).

Combination tablets indicated for the treatment of HIV infection. Each tablet contains 150 mg lamivudine (Epivir®, 3TC)/300 mg zidovudine (Retrovir®, AZT, ZDV, azidothymidine) and is to be taken twice daily. For patients on multidrug therapy, many of whom take as many as 20 pills a day, use of Combivir will reduce by six the number of pills taken. Combivir is a fixed-dose combination tablet and should not be used in patients who require dose modification of lamivudine or zidovudine. Retrovir, therefore, will continue to be available in 300-mg tablets, 100-mg capsules, syrup, and intravenous solution; Epivir will continue to be available in 150-mg tablets and oral solution. Mfg: Glaxo Wellcome. .

The first in a new class of drugs known as antitumor vascular targeting agents, combretastatin was shown in animal studies to reduce the blood flow to tumors and to enhance response to radiation. Reduction of blood flow cuts off the supply of oxygen and nutrients required for tumor cell survival and growth. The drug is in early clinical trials for the treatment of solid tumors in humans. Mfg: OxiGene.

Full line of guide wires designed specifically for PTCA (percutaneous transluminal coronary angioplasty) procedures. Product line includes SR (stent-ready) series guide wires for coronary stent placement procedures. Mfg: C. R. Bard.

A formulation of low-dose D9-THC (delta-9-tetrahydrocannabinol) in clinical trials for the treatment of dementia.

Another name for reflex sympathetic dystrophy (RSD), a syndrome characterized by pain and tenderness associated with vasomotor instability, skin changes, and rapid development of bony demineralization (e.g., osteoporosis) often following localized trauma, stroke, or peripheral nerve injury.
CRPS type I (or type 1, depending on reference): as above without the presence of a definable nerve lesion;
CRPS type II (or type 2), a.k.a. causalgia: relates to cases where a definable nerve lesion is present.
Medline - Reflex Sympathetic Dystrophy: changing the concepts and taxonomy; Pain: 63:127-133, 1995.

Packaging for combination of Trovan® (trovafloxacin)/Zithromax® (azithromycin). Indication: single-dose treatment of sexually transmitted diseases (STDs): (1) uncomplicated urethral gonorrhea in males and endocervical and rectal gonorrhea in females caused by Neisseria gonorrhoeae, (2) nongonococcal urethritis and cervicitis due to Chlamydia trachomatis. The Compliance Pak includes a 100-mg trovafloxacin tablet and a packet containing 1 g (1000 mg) azithromycin oral suspension, which is to be mixed with water prior to administration. Mfg: Pfizer Inc.

Bioengineered dressing indicated for stimulation and regeneration of human skin tissue, presently in clinical trials as an alternative to autograft in patients requiring skin grafting due to severe burns and treatment of dermal ulcers in patients with epidermolysis bullosa (EB). Update: The FDA has granted HUD (humanitarian use device) designation of CCS for the treatment of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. In clinical trials; not FDA approved. Mfg: Ortec International (212-740-6999).

Indicated for ventral hernia repair; comprised of Bard mesh on one side for tissue ingrowth and bonded to ePTFE on the other side for prevention of adherence to other tissues and adhesion formation. Mfg: Davol/Bard - 10/24/98.

Brand name generic; equivalent to SmithKline Beecham's Compazine® 25 suppositories. Indications: control of severe nausea and vomiting; management of manifestations of psychotic disorders. Mfg: Paddock Laboratories, Inc.

Noninvasive diagnostic system utilizes thermal sensing and computer software to create digital images from infrared-heat patterns of the body. System components: Infrared Imaging Optics program, Quantitative Thermal Analysis™ (QTA™) lab, proprietary protocol and procedures, image analysis algorithms and software, national image database, CTI™ Health Card (a patient card that stores the patient's digital images for future comparison). Mfg: Computerized Thermal Imaging, Inc..

Sleep study systems for the diagnosis and analysis of sleep disorders such as sleep apnea syndrome. Mfg: Compumedics. Distributor: ResMed.

P-Series is an 18-channel portable system for sleep lab, hospital or home use.
S-Series is a 20-channel system for clinical use in sleep labs.

Diagnostic device utilizing laser technology to produce a three-dimensional cross-section image of the breast, providing a painless diagnostic tool without use of x-ray. Presently approved for human clinical trials. Mfg: Imaging Diagnostic Systems, Inc.

A new class of drug that enhances the effectiveness of levodopa by blocking the COMT enzyme, one of the main enzymes responsible for breaking down levodopa in the bloodstream before it reaches the brain. Increasing levodopa bioavailability to the brain helps to achieve a more steady and continuous dopaminergic stimulation, which translates into more consistent and effective symptom relief for Parkinson patients.

A COMT inhibitor. Indication: adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson disease who experience the signs and symptoms of end-of-dose "wearing-off." Comtan helps to improve motor performance by extending the positive effects of levodopa/carbidopa, allowing patients to function more independently for longer periods of time between doses. Dosage and administration: One 200-mg tablet administered concomitantly with each levodopa/carbidopa dose to a maximum of 8 times daily (maximum daily dose, 1600 per day). See product monograph [Acrobat required] for additional information. Mfg: Orion Pharma (Finland); co-marketed by Orion Pharma and Novartis.

Single-use device indicated for ablation of soft tissue during arthroscopic knee and shoulder procedures. Mfg: ConMed/Linvatec Div.

Indicated for diagnosis of fallopian tube disorders.

Extended-release tablets, based on OROS® technology, indicated for the treatment of ADHD (attention deficit hyperactivity disorder) in patients age 6 and older. Administration: single tablet once daily in the morning with or without breakfast. Dosage form: 18- and 36-mg tablets. See product monograph for additional information. Mfg: Alza Corporation; marketed by Alza and McNeil Consumer Healthcare, div. of Johnson & Johnson.

Compression hip screw used in conjunction with the Medoff sliding plate for fixation and stabilization during hip repair procedures.

Rapid pregnancy test designed for use by clinical laboratories. Mfg: Quidel Corporation.

Also ACS Concorde™ - balloon dilatation catheter.

Investigational procedure uses radiofrequency energy to correct low to moderate levels of hyperopia (farsightedness); phase III clinical trials are underway and have been approved for treating both eyes on the same day. Future indications may include treatment of astigmatism, presbyopia, and overcorrection/undercorrection from LASIK procedures. The study uses the Refractec ViewPoint™ CK system. Mfg: Refractec, Inc.

For local topical treatment of external genital and perianal warts, with easier application than previously approved Condylox® solution. Mfg: Oclassen Pharmaceuticals.

System for delivery of proton beam therapy; indicated for cancer treatment, macular degeneration, and arteriovenous malformations. Proton beam therapy delivers radiation directly to the targeted site with a minimal entrance dose and no exit dose, thereby leaving healthy peripheral tissue largely unharmed. Due to minimal side effects, patients can be treated as outpatients and return home or to work after treatment. For treatment information, contact the Loma Linda University Medical Center. Mfg: Optivus Technology, Inc.

Device that shapes radiation beams for treatment of irregularly shaped tumors in the cranium, head, neck, and other areas, delivering an increased radiation dose to the tumor with a decreased dose to the adjacent healthy tissue. Mfg: Radionics.

Multiple-electrode mapping catheter for evaluation and diagnosis of complex right atrial tachycardia. Mfg: Boston Scientific.

Device designed specifically for the treatment of CHF provides biventricular pacing stimulation to both the right and left sides of the heart, cardioversion, and defibrillation. The EasyTrak™ leads are placed transvenously over a guide wire. Not FDA approved; beginning <AHREF="C.SHTML#CLINICALTRIALS"clinical trials. Mfg: Guidant.

Catheter system for urinary drainage. CE Mark approved; not yet FDA approved. Mfg: ContiMed, Inc. (612-829-4057).

Device automatically collects platelets while removing leukocytes from donated blood. Mfg: Haemonetics Corporation.

Dilatation catheters with balloons that inflate to a larger diameter at the proximal end and taper to a smaller diameter at the distal end. Mfg: CardioVascular Dynamics - 714-457-9546.

Ultrasonic-assisted liposuction system provides improved contouring capabilities and decreased trauma with faster patient recovery period. Approved in Canada. Mfg: Mentor Corporation.

Small design, single-lead, high energy defibrillator for treatment of rapid heart beat, provides 42 joules of stored energy with ability to record and store up to 16 minutes of continuous electrogram as a diagnostic aid. Mfg: Ventritex.

A thin-profile (15-mm) implantable cardioverter-defibrillator indicated for patients who require maximum-energy defibrillation. Mfg: St. Jude Medical.

Provides cardioversion and defibrillation shock without antitachycardia pacing. The LT V-135D as well as the V-145D IDC (below) provide up to 16 minutes of continuous electrogram storage. Mfg: Ventritex, Inc.

Able to deliver antitachycardia pacing (ATP) therapy as well as low-energy shock and high-energy defibrillation shock. Mfg: Ventritex, Inc.

A recombinant formulation of a natural protein in phase II/III clinical trials for the treatment of scleroderma. Mfg: Connetics Corporation.

See Stratasis™ urethral sling.

Related to vestibular rehabilitation or movement therapy for treating vestibular problems.

Long-pulse Nd:YAG laser indicated for hair removal and the treatment of vascular lesions. Mfg: Altus Medical.

Device uses thermal energy for the performance of general dermatologic procedures. Clinical studies are completed for the use of this device in the treatment of facial wrinkles (see thermescent skin treatment). Mfg: Laser Aesthetics.

Previously known as copolymer-1, Copaxone is a noninterferon, nonsteroidal medication that reduces the frequency of relapses in patients with relapsing-remitting multiple sclerosis. Note: A needleless injection system for self-administration of Copaxone is being developed by Medi-Ject Corporation. Marketed by Teva Marion Partners.

Injectable collagenase in clinical trails for the treatment of Dupuytren disease, Peyronie disease, and keloids. Collagenase has previously been designated by the FDA as an orphan drug for the treatment of Dupuytren disease. Mfg: BioSpecifics Technologies Corp.

An investigational cytoprotective drug to prevent ischemia-induced tissue damage. Product is in phase III trials in patients with sickle cell anemia and in patients undergoing CABG surgery. Future clinical trials may involve the use of Cordox for a variety of inflammatory or immunosuppressant indications, including treatment of asthma, preservation of donor organs, and inhibition of host rejection in organ transplants. Mfg: Questcor Pharmaceuticals, Inc. (formerly Cypros Pharmaceutical Corp.).

Thermometer providing accurate core readings in seconds intra-aurally.

Neurohormonal antagonist with beta-blocking, vasodilating and antioxidant properties for treatment of congestive heart failure. Mfg: SmithKline Beecham/Roche (formerly Boehinger Mannheim).

New name for the Coricidin® line of over-the-counter decongestant-free products for the treatment of cold and flu symptoms. Mfg: Schering-Plough.

Anchoring device for soft bone fixation during arthroscopic repair of rotator cuff injuries.

A dopamine DA1 agonist which, according to studies, appears to have specific beneficial effects on both the cardiovascular system and the kidney. Clinical trials to document the effects of Corlopam on the kidney of healthy subjects have been completed, and additional studies are planned which will focus on the action of the drug in both hypertensive patients and those with compromised renal function. Corlopam may be of benefit in several indications, including blood pressure control, malignant hypertension, congestive heart failure, and acute renal failure. It is already approved in several European markets for blood pressure control. Update: FDA approved for in-hospital, short-term (up to 48 hours) management of severe hypertension, including malignant hypertension with deteriorating end-organ function, when rapid, but quickly reversible, emergency reduction in blood pressure is clinically indicated. Method: infusion. Mfg: Neurex Corporation.

See LTK™ (laser thermal keratoplasty) system.

An antiviral nucleoside analogue currently in phase II trials for the treatment of HBV (hepatitis B virus) and in phase III trials for the treatment of HIV and AIDS. Mfg: Triangle Pharme -

Sprayable sealant indicated for surgical closure during cardiovascular procedures. In clinical trials; not FDA approved. Mfg: Cohesion Technologies.

Vascular clamp used to temporarily occlude a blood vessel; indicated for use in pulmonary and gastrointestinal procedures, minimally invasive and standard open cardiovascular procedures; can be used to clamp over indwelling catheters. Mfg: Allegiance Healthcare Corporation (847-473-1500).

Electrosurgical

Procedure name coined by Luxar, describing new "30-minute" facial cosmetic surgery performed with their NovaPulse laser and NovaScan laser scanning system for removing scars, blemishes, birthmarks, and smoothing sun-aged skin.

Indication: reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension inadequately controlled with beta-blockers alone. Administration/dosage: one drop of Cosopt in the affected eye(s) twice daily. Cosopt is a combination of two medications available as single agents from Merck, dorzolamide hydrochloride (Trusopt®) and timolol maleate (Timoptic®), and is supplied in an Ocumeter® dispenser with a controlled drop tip. Mfg: Merck & Co.

An atraumatic, bioresorbable, liquid hemostat designed for use as a spray to control bleeding in hepatic, orthopedic, cardiothoracic, and general surgical procedures. Currently in clinical trials. Mfg: Cohesion Technologies.

Sprayable hydrogel indicated for the prevention of postoperative adhesions. Currently in development and not FDA approved.

A chimeric monoclonal antibody labeled with I¹³¹ for tumor necrosis therapy (TNT) in the treatment of cancer. Currently in phase II clinical trials in the United States for the treatment of malignant glioma in patients diagnosed with glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). Additional trials for the treatment of solid tumors in patients with cancer of the prostate, pancreas, and liver are being conducted in Mexico. Mfg: Techniclone Corporation.

Anticoagulant prescribed for prophylaxis and treatment of thromboembolic disorders is now available in individual tablet strengths of 3 mg and 6 mg to allow for more precise dosing. Mfg: DuPont Pharma.

Clinical trials to evaluate the long-term effects of coronary angioplasty versus intensive drug therapy in patients with symptomatic heart disease to take place at VA and non-VA medical centers and scheduled to run until the year 2005. The trials are jointly funded by the Veteran's Administration, the Canadian Medical Research Council, and various pharmaceutical firms. COURAGE is an acronym for clinical outcomes utilizing revascularization and aggressive drug evaluation. CoverTip™ safety syringe

Safety syringe indicated for intramuscular injection and designed to prevent accidental needle sticks. Mfg: Medisys.

A class of arthritis drug for relief of pain without causing the side effects, e.g., ulcers, bleeding, and other digestive tract problems, that can be experienced with NSAIDs. Conventional NSAIDs have an effect on cyclooxygenase 1 and 2 (COX-1, COX-2). The COX-1 protein protects the lining of the stomach, so blocking its action is what leads to the above-mentioned side effects. Blocking the action of the COX-2 protein is thought to be all that's needed to relieve arthritis pain without serious complication.

Provides positive pressure in order to maintain an open airway during sleep as a treatment for obstructive sleep apnea (OSA).

External counter-pulsation device in clinical trials for noninvasive treatment of angina and coronary artery disease (CAD). Mfg: CPC of America (941-906-9546).

Investigational agent for improved organ protection during heart-lung bypass procedures. An IND (investigational new drug) application has been cleared by the FDA, and human clinical trials are scheduled to begin. Mfg: LXR Biotechnology Inc.

C-peptide (protein)

Studies have shown that C-peptide (a protein released as a by-product when the body produces insulin), when injected in high doses, was found to repair blood vessels and nerve damage found in diabetic rats. The C-peptide protein is found in significantly decreased amounts in type 2 diabetic patients and is absent in most type 1 diabetic patients. Scientists hope further studies will lead to a treatment for diabetics which will prevent both vascular and neurologic damage.

Used in patients requiring mitral valve replacement, the OptiForm mitral valve has a flexible sewing cuff that can be sculpted to fit mitral annular anatomy thus ensuring tissue compliance with the valve. CPHV is an acronym for Carbomedics prosthetic heart valve; Sulzer Carbomedics is a division of Sulzer Medica.

In Phase I/II clinical trials in patients with cystic fibrosis. The trials are to establish the safety and pharmacokinetic parameters of CPX in addition to its ability to normalize chloride secretion by defective CF cells via repairing the basic molecular defect at the root cause of CF. Developed by SciClone Pharmaceuticals, Inc.

Valved infusion catheter which may be used in conjunction with the ProStream™ infusion wire. Mfg: Micro Therapeutics.

Indicated for disruption and dissolution of blood clots in hemodialysis grafts by mixing urokinase (a thrombolytic agent) with the clot. Mfg: Micro Therapeutics.

Vaccine against diphtheria, tetanus, and acellular pertussis (DTaP). Following FDA approval, Cretiva will be marketed by Abbott Laboratories. Mfg: North American Vaccine, Inc..

Natural progesterone in a bioadhesive gel indicated for the treatment of secondary amenorrhea. Product will be packaged in a pre-filled vaginal applicator; one applicator (45 mg). Marketed by Wyeth-Ayerst Laboratories.

Vaginally delivered directly to the uterus, progesterone gel is indicated for the treatment of infertility in women as a progesterone supplement or replacement. Marketed by Wyeth-Ayerst Laboratories.

Multielectrode catheter for mapping of the atrial endocardium for diagnosis of atrial arrhythmia and tachycardia.

An HIV protease inhibitor approved, under the provisions of the FDA's accelerated approval process, in March 1997 for the treatment of HIV infection in adults when antiretroviral therapy is warranted. Traditional approval was granted in February 1998 following submission and review of additional clinical trial data. Crixivan may be used alone or in combination with other antiretroviral agents and is available in 200- and 400-mg capsules for oral administration. For additional information, see manufacturer's Crixivan home page. Mfg: Merck.

Stent for improving luminal diameter and maintaining patency in ischemic coronary arteries secondary to discrete de novo or restenosis of native coronary arteries; an over-the-wire product that is placed via a balloon catheter during PTCA procedures. A 1-mm balloon-overhang limitation is designed to prevent dog boning. Available diameters: 3.0 mm, 3.5 mm, 4.0 mm. Available lengths: 13 mm, 18 mm, 23 mm, Webster; div. of Johnson & Johnson.

Balloon dilatation catheter used in percutaneous transluminal coronary angioplasty (PTCA) procedures; indicated for restoring flow in partially and fully occluded coronary arteries and bypass grafts. Available in 38 sizes, including 4.5 mm and 5.0 mm for treatment of larger diameter vessels. Mfg: Guidant Corporation.

An antivenom used to neutralize the effects of bites inflicted by the crotalid family of snakes, e.g., pit vipers, rattlesnakes, copperheads, and cottonmouths. CroTAb is a designated orphan drug; however, the manufacturer has submitted a PLA (product license application) requesting marketing clearance. If cleared by the FDA, CroTAb will be marketed in the United States by Altana, Inc.

See ENT-Tonsillectomy.

See Palmaz-Schatz® Crown balloon-expandable stent.

See complex regional pain syndrome.

Device designed for continuous monitoring of temperature levels during cryoablation procedures, allowing the system to shut down when tissue freezing has been achieved, reducing the risk of damage to surrounding healthy tissue; available in 4-probe and 8-probe systems. Targeted Ablation Therapy™ (TAT) and Targeted CryoAblation Therapy™ (TCAT) are registered trademarks of Endocare.

CRYOguide™

Software-controlled ultrasound planning and guidance system for use with the CRYOcare™ system; indicated for treatment of malignant tumors and benign prostatic hypertrophy. Three-dimensional visualization affords more precise probe placement at the targeted site. Not FDA approved. Mfg: Endocare, Inc.

System for automatic harvesting of adhesive and blood proteins from blood plasma for the production of cryoprecipitated ("Cryo") AHF, which is used for intravenous treatment of hemophilia. Cryo is also used to stop bleeding and as a tissue sealant during surgical procedures as an alternative to fibrin sealant or fibrin glue. Mfg: ThermoGenesis.

For treatment of cryptosporidial diarrhea (see cryptosporidiosis) in AIDS patients. An NDA requesting clearance to market for this indication has been submitted and is pending FDA review. Mfg: Romark Laboratories.

Sometimes referred to as "crypto," cryptosporidiosis is an intestinal infection caused by Cryptosporidium parvum, a water- and food-borne parasite. The CDC considers chronic intestinal cryptosporidiosis (one month or greater duration) to be an AIDS-defining condition. See CDC's cryptosporidiosis fact sheet.

See Stretta™ system

See Gen-Probe amplified CT assay.

See computed tomography laser mammography.

A cancer vaccine in phase II safety and efficacy trials in patients with colorectal cancer. Trials concerning use of the CTP37 vaccine in the treatment of pancreatic cancer are ongoing, and trials related to the treatment of breast cancer and prostate cancer are expected to begin before the end of 1997. Co-developed by Arkios BioDevelopment International and ImmunoTherapy Corporation.

Accessory device to CTS MIDCAB™ system for use in harvesting the internal mammary artery (IMA) during MIDCAB procedures and saphenous vein harvesting, utilizing bipolar cutting and cauterization technique. Mfg: Guidant Corporation.

See Voyager Aortic IntraClusion device.

Manufacturer of endoscopes, laparoscopes, retractors.

A porcine-derived lung surfactant for the treatment of respiratory distress syndrome (hyaline membrane disease) in premature infants. Marketed in the U.S. by Dey, Inc.

Investigational device for measuring optical aberrations of the eye; the information is transmitted to the LADARVision system to create a custom wavefront ablation pattern for reshaping the cornea of the eye to correct vision. Mfg: Summit Autonomous.

Nonabsorbable, synthetic, polyamide suture for use in general and plastic surgical procedures. Mfg: Genzyme Corporation.

A midpotency topical corticosteroid for relief of inflammation and pruritus associated with corticosteroid-responsive dermatoses. Expanded indication: treatment of atopic dermatitis in infants and children three months of age and older. Previously indicated for treatment of patients 12 years of age and older. Recommended dosage/administration in pediatric patients: a thin film applied once or twice daily to affected skin areas; see product literature [Acrobat required] for additional information. Mfg: Glaxo Dermatology, a division of Glaxo Wellcome, Inc.

Microsurgical dilatation catheter system for the treatment of coronary artery disease. Indication: dilatation of stenoses in coronary arteries to improve myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. The Cutting Balloon consists of conventional dilatation balloon with three or four microsurgical blades [Atherotome™(s)] longitudinally positioned on its surface. The blades are shielded when the balloon is being positioned in the artery, but as the balloon is inflated, they extend radially and incise the lesion ahead of the expanding balloon. Mfg: Interventional Technologies.

Cardiovascular patch designed for numerous cardiovascular indications including repair of great vessels, valvuloplasty, ventricular and atrial septal defects, and reinforcement of aortic graft suture lines. Mfg: Bio-Vascular.

Lead removal sheath removes pacemaker leads by passing the sheath over the lead, ablating scar tissue formed around it with short bursts of laser energy, allowing for ease of removal. See Spectranetics Laser Sheath. Mfg: Spectranetics.

Former trademark name; see Lunelle™.

Former trademark name; see Lunelle™.

For use by transplant recipients, the hand-held device is designed to promote medication compliance by providing preprogrammed dosing of oral cyclosporine solution, an alarm to alert patients to take medication, and maintains a record of each dose taken; awaiting FDA approval. Mfg: SangStat.

Pharmaceutical agent in phase III clinical trials for the treatment of hot flashes experienced by prostate cancer patients following surgical or chemical castration.

Indicated for the treatment of patients with homocystinuria, a rare, genetic disorder caused by various inborn errors of metabolism. Mfg: Orphan Medical.

In Phase II clinical trials to evaluate its ability to mitigate reperfusion injury which often follows cardiopulmonary bypass used in surgery. These trials are referred to as CALYPSO trials. Cylexin is also being studied relative to its use as an aid in improving the postoperative course of surgery to correct congenital heart defects in newborn infants. Mfg: Cytel Corporation.

An injectable form of AlloDerm® consisting of small particles of processed acellular human tissue matrix. Packaged as a dry powder which is reconstituted, delivered by syringe, and used for nonsurgical soft tissue replacement procedures by plastic and facial surgeons and dermatologists. Co-marketed by Obagi Medical Products.

Expanded indication: prophylaxis against cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants. Previously indicated for use only in CMV-seronegative patients receiving kidney transplants from CMV-seropositive donors. See monograph for additional information. Mfg: MedImmune, Inc.

Former trademark name; see Locilex™.

Cytolin, a monoclonal antibody directed at a specific subset of CD8 cells which target CD4 cells, bolstering up the immune system. Initiation of clinical trials to determine efficacy in the treatment of HIV was approved by the FDA in October 1996. Mfg: CytoDyn.

A class of drug designed to selectively protect healthy tissues while allowing anticancer drugs to destroy malignant cells.

Approved for prophylactic use to prevent cytomegalovirus (CMV) in at-risk patients who receive heart, lung, pancreas, kidney, or liver transplants. Previously, only intravenous Cytovene was indicated as preventive therapy for CMV disease in solid organ transplant recipients. Mfg: Hoffmann-La Roche.

Rigid stent introducer and endoscope used for insertion of tracheal stents. Mfg: E. Benson Hood Laboratories (a.k.a. Hood Laboratories).