BIOTRONIK Receives Approval for Phylax AV Implantable Defibrillator.Business Editors LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Oct. 2, 2000 Biotronik, Inc. announced today the Phylax AV 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. ) received approval by 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. ). This device represents BIOTRONIK's first dual-chamber implantable defibrillator released in the U.S. into the rapidly growing tachyarrhythmia tachyarrhythmia /tachy·ar·rhyth·mia/ (tak?e-ah-rith´me-ah) any disturbance of the heart rhythm in which the heart rate is abnormally increased. tach·y·ar·rhyth·mi·a n. market. The Phylax AV, featuring SMART Detection(TM), is one of the most sophisticated detection algorithms available for the discrimination of ventricular tachycardias and supraventricular tachycardias. Designed to increase specificity while maintaining sensitivity, SMART Detection(TM) demonstrated 94% specificity while maintaining 100% sensitivity in clinical trials. The high specificity rate reduces unnecessary or inappropriate delivery of therapy to those patients whose atrial-based tachyarrhythmias are not considered life threatening, while treating tachyarrhythmias that may be potentially fatal. The Phylax AV provides an extensive array of diagnostic capabilities to assist the physician in making informed clinical decisions. This includes up to 16 minutes of high fidelity heart rhythm recordings (IEGMs). Other competitive features include SMART Success IEGM storage, Mode Conversion with programmable ventricular rate support, Dynamic AV Delay to mimic normal physiologic shortening with exercise, Real-time IEGMs to facilitate troubleshooting and programming, along with a sophisticated EP Test Mode to evaluate defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. therapy thresholds and the efficacy of anti-arrhythmic drug therapy. The approval of the Phylax AV complements BIOTRONIK's existing line of single chamber ICD products. With several additional generations entering clinical trials and the FDA approval process, BIOTRONIK continues its aggressive stance of rapidly entering the U.S. cardiac rhythm market (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ). BIOTRONIK, a world leader in the cardiovascular device industry, is committed to the research and development of new biomedical products. The company's North American headquarters is located in Lake Oswego, Oregon Lake Oswego (IPA: ɔs wiː ɡo) is a city in Clackamas County, Oregon, United States. (Small parts of the city extend into Multnomah County to the north and Washington County to the west. , with worldwide headquarters in Berlin, Germany. |
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