BIOTRONIK Announces the First Implantation of the Tachos DR Implantable Cardioverter Defibrillator.

Business Editors, Medical/Health Writers

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--March 14, 2001

Biotronik, Inc. announced today the first implantation of the Tachos DR implantable cardioverter defibrillator (ICD), which was recently approved by the U.S. Food and Drug Administration (FDA).

Dr. John Beard performed the first U.S. implantation of the Tachos DR at Providence Hospital in Columbia, S.C., in a 65-year-old patient with a history of paroxysmal atrial fibrillation and ventricular tachycardia. This device represents BIOTRONIK's latest dual-chamber, rate-adaptive implantable defibrillator to be released into the rapidly growing tachyarrhythmia market.

The Tachos DR features SMART Detection(TM), one of the most sophisticated detection algorithms available for the discrimination of ventricular tachycardias and supraventricular tachycardias. SMART Detection(TM) demonstrated 94% specificity while maintaining 100% sensitivity during the clinical trials of the Phylax AV ICD. 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. Additionally, the Tachos DR includes SMART Redetect, a feature designed to prevent inappropriate therapies to patients with SVT's that occur immediately after ventricular therapy delivery.

The new ICD platform provides an extensive array of diagnostic capabilities to assist the physician in making informed clinical decisions. This includes accelerometer-driven rate-adaptation and up to 64 minutes of single-chamber or 32 minutes of dual-chamber high fidelity heart rhythm recordings (IEGMs). Other competitive features include SMART Success IEGM storage, Mode Switching, Real-time IEGMs to facilitate troubleshooting and programming, as well as a sophisticated EP Test Mode to evaluate defibrillation therapy thresholds and the efficacy of anti-arrhythmic drug therapy.

The approval of the Tachos DR complements BIOTRONIK's existing line of ICD products. With several additional generations entering clinical trials and the FDA approval process, BIOTRONIK continues its rapid expansion within the U.S. Cardiac Rhythm Market (CRM).

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, with worldwide headquarters in Berlin, Germany.