Ventritex Files PMA Supplement for its Contour Implantable Cardioverter Defibrillator; First European Implants of Smallest, Thinnest Defibrillator.SUNNYVALE, Calif.--(BUSINESS WIRE)--June 13, 1996--Ventritex, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : VNTX) today announced the filing of a Premarket Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) Supplement with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) seeking marketing clearance for its Contour(TM) implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) -- the smallest and thinnest ICD developed for patients with abnormally rapid heart rhythms. The company also announced that the first implants of the Contour ICD took place this week in Germany. At 15 millimeters thin, 57 cubic centimeters in volume and with a contoured case having rounded edges, the Contour ICD is designed to provide enhanced patient comfort and facilitate implantation in the pectoral pectoral /pec·to·ral/ (pek´ter-il) thoracic. pec·to·ral adj. 1. Relating to or situated in the breast or chest. 2. (chest) region. The initial two implants of the Contour device were performed by Dr. Hans-Joachim Trappe at Marienhospital in Herne, Germany. The third implant was performed by Dr. Malte Meesmann at University Hospital in Wuerzburg, Germany. In all cases, the patients received the Contour HVC HVC Haifa Verification Conference HVC Holographic Versatile Card (digital storage medium) HVC High Velocity Cloud (galactic cloud made of mostly atomic hydrogen) HVC Hue-Value-Chroma defibrillator, which utilizes the defibrillator case as one of the electrodes. The Contour device is the smallest, thinnest defibrillator implanted in a patient thus far. It also offers the highest energy output (38 joules delivered) and the most electrogram storage capability (16 minutes) available in any pectoral ICD. Pioneered by Ventritex, stored electrograms give physicians a record of cardiac activity before, during and after each arrhythmic ar·rhyth·mic adj. Lacking rhythm or regularity of rhythm. episode, improving patient diagnosis and management. "We designed the Contour defibrillator to offer physicians an optimum combination of features, including the smallest size, thinnest profile, greatest safety margin and most diagnostic information," said Frank Fischer, Ventritex president and chief executive officer. "The Contour ICD is a tremendous advance for Ventritex, as we continue to develop ever-smaller devices without compromising important clinical capabilities." Ventritex was founded in 1985 to develop, manufacture and sell implantable defibrillators and related products for the treatment of ventricular tachycardia and ventricular fibrillation, the most serious and life-threatening forms of abnormal heart rhythms. The company has been an innovator in the field of ICD technology since it introduced the Cadencer V-100 defibrillator in 1989. The company employs more than 500 people and maintains a 150,000-square-foot facility in Sunnyvale, California. CONTACT: Ventritex Inc. Frank M. Fischer or Michael B. Sweeney, 408/738-4883 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion