BIOTRONIK Announces the First U.S. Implant of its New Active Capture Control Pacemaker.

Business Editors, Health/Medical Writers

LAKE OSWEGO, Ore.--(BW HealthWire)--Feb. 14, 2002

BIOTRONIK, Inc., today announced the first U.S. investigational implant of its new Philos DR ACC pacemaker featuring Active Capture Control (ACC) as part of a multi-center study.

ACC represents the next step in capture management. ACC ensures that on every beat, the pacemaker delivers the minimal energy necessary to effectively stimulate the patient's heart. ACC achieves this goal by using sophisticated analyses that go beyond simple templating. As a result, it is anticipated that ACC will help improve patient outcomes by prolonging battery life while ensuring complete patient safety.

Dr. Barry Weinstock at Northside Hospital and Heart Center in St. Petersburg, FL performed the implantation procedure in an 87-year old patient with sinus bradycardia. The Philos DR ACC was implanted with two BIOTRONIK Fractal leads -- an active-fixation Elox in the atrium and a high impedance, passive-fixation Synox in the ventricle. Fractal Lead Technology has clinically proven itself superior to other technologies by delivering significantly better chronic sensing performance, making it the choice for clear sensing of the heart's electrical activity. ACC takes advantage of this undistorted sensing. In pre-clinical studies, ACC demonstrated 99.7% sensitivity to non-capture detection.

As noted by Dr. Weinstock, BIOTRONIK's ACC is the industry's only capture management feature to use a bipolar configuration for pacing, sensing, and the beat-to-beat back-up safety pulse. "The bipolar algorithm used in the Philos DR ACC pacemaker is an advance compared to earlier unipolar based algorithms." The impact of which may, as stated by Dr. Weinstock, "... allow capture confirmation to be used in patients who may later require ICDs." The Food and Drug Administration prohibits the use of unipolar pacing modes with Implantable Cardioverter Defibrillators (ICD), as they may potentially interfere with the operation of the ICD.

In addition, ACC is also the only such feature to automatically adjust its minimal energy output based on the patient's pacing threshold, a physician-selected safety margin, and a clinically appropriate minimum output. With this flexibility, the physician is able to provide the patient with a pacemaker that delivers energy-efficient outputs and safety margins, which take into account changes caused by medications and other clinical variables, while still delivering safe, effective therapy. Several diagnostics are committed to tracking and verifying the performance of ACC including a long-term threshold trend that tracks measured thresholds up to 4.5 months.

BIOTRONIK, a world leader in the cardiovascular device industry, is committed to the research and development of new biomedical products. The company's U.S. headquarters is located in Lake Oswego, Oregon, with worldwide headquarters in Berlin, Germany.