BIOTRONIK Announces FDA Approval of ACTROS SLR+ Pacemaker VDDR System.

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Sept. 3, 1999--

BIOTRONIK, Inc. today announced clearance by the Food and Drug Administration of the thinnest, most full-featured VDDR pacing system to enter the cardiac rhythm management market -- ACTROS SLR+ pacemaker and the SL-BP lead.

This new VDDR pacing system's key clinical advantage is its ability to reliably track healthy sinus rhythms using a single-pass dual-chamber pacing lead. This attribute makes ACTROS SLR+ the ideal pacing system for patients whose healthy sinus (atrial) rhythm is unable to conduct to the ventricle due to high degree heart block. As a result, these patients may enjoy the physiologic advantage of AV synchrony with minimal hardware.

As with the rest of BIOTRONIK's flagship family of ACTROS+ bradycardia pacemakers, ACTROS SLR+ pacemaker is only 10 cc and 6 mm making it the smallest, thinnest, and most versatile full-featured VDDR pacemaker available.

The SL-BP single-pass dual-chamber pacing lead is key to ACTROS SLR+s reliable therapy. The lead features BIOTRONIK's exclusive Fractal Lead Technology(TM), which during the clinical trial facilitated sensing of chronic stable P waves of greater than 1.3 mV. When compared to the published P wave clinical results of other market-released VDDR systems, the P waves sensed by the SL-BP lead are 20% larger.

The excellent sensing performance of the SL-BP lead combined with the ACTROS SLR+ s sensitivity programmability, enhanced therapies and comprehensive diagnostic packages makes this system the most versatile VDDR pacing systems available.

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.