Ventritex Receives FDA Clearance for its Contour HVC and Cadet HVC Implantable Cardioverter Defibrillators; High Voltage Can Devices Simplify Implantation Procedures.SUNNYVALE, Calif.--(BUSINESS WIRE)--Nov. 8, 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 that 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. ) has granted the company approval of its Premarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. (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 ) Supplements to commercially release the Contour (TM) High Voltage Can (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 ) and the Cadet (R) HVC implantable cardioverter defibrillators (ICDs) for the treatment of patients with abnormally rapid heart rhythms. These ICDs utilize the 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 case itself as an additional electrode. As a result, the devices can be implanted with a single lead, simplifying implantation procedures. The Contour ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. , cleared for commercial release on September 19, 1996, is the smallest, thinnest and most powerful pectorally labeled device currently marketed in the United States. At 15 millimeters thin, 57 cubic centimeters (cc) in volume, 109 grams in weight, and featuring a contoured case with rounded edges, the Contour ICD is designed to enhance 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. With 42 joules of stored energy, the Contour device provides high energy output for greater patient safety, as well as 16 minutes of continuous electrogram storage for improved patient diagnosis and management. Ventritex's ability to significantly reduce ICD size, customize ICD shape and maintain high energy output is made possible through the use of proprietary Flatcap (TM) capacitors manufactured by the company's Maven division. The 73 cc Cadet defibrillator was first introduced for pectoral implantation in May 1996. Like the Contour ICD, Cadet is now available in a high voltage can version, maintains 42 joules of stored energy, and provides up to 16 minutes of stored electrograms. "The availability of high voltage can versions of the Contour and Cadet implantable defibrillators provides physicians with the first Ventritex single lead system," said Frank Fischer, Ventritex president and chief executive officer. "Now physicians seeking the advanced features of Contour and Cadet ICDs can minimize implant time as well." 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 Cadence(R) 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., Sunnyvale Frank M. Fischer or Michael B. Sweeney, 408/738-4883 |
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