BIOTRONIK Announces FDA Approval of Its Proprietary Closed Loop Stimulation Pacemaker Technology.

Business Editors

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Oct. 25, 2001

BIOTRONIK, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved commercial release of its proprietary Closed Loop Stimulation (CLS) technology.

The approval marks the first new rate-adaptive sensor for the 21st Century. Market release of CLS signifies another important step for BIOTRONIK as an industry leader in both technology and patient care.

The development of CLS has been driven by the desire to provide patients with heart rate adaptation based on their own cardiovascular control system. CLS monitors changes in a physiologic parameter, cardiac contractility. This method is in marked contrast to other current, market-released devices that use only simple changes in body motion and/or respiration to trigger changes in the pacing rate during exercise. After decades of sensor development by the pacemaker industry, CLS has emerged as the next great step toward true physiologic heart rate control by an implantable pulse generator.

The approval from FDA is based on the results of a multi-center clinical investigation evaluating the rate-adaptive performance of CLS in a dual-chamber pacemaker. The study was designed to evaluate the effectiveness of CLS rate adaptation during both exercise testing and the patient's daily activities. The results show that CLS provides the expected heart rate response to exercise and to the patient's daily activities.

In addition to exercise, a healthy heart responds to many factors, including emotions, illness, and the body's natural rhythms. Multiple international studies have suggested that CLS responds to a variety of non-exercise stressors. Further studies of CLS will examine the system's heart rate response to these types of stress using an approved research platform. BIOTRONIK will continue to provide customers with patient-relevant pacing therapy by integrating CLS into the next generation of pacemaker technology.

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.