BIOTRONIK Announces FDA Approval of Its Home Monitoring Technology.

Business Editors, Health/Medical Writers

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Oct. 11, 2001

BIOTRONIK, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the commercial release of Home Monitoring, the world's first state-of-the-art, wireless communication system for remote monitoring of implantable pacemakers.

With the new Home Monitoring System, a patient's BIOTRONIK pacemaker is now able to automatically transmit critical data about the patient's current condition to his or her physician's office, anytime, anywhere. The wireless system requires no patient involvement and is completely mobile. This means that patients are free to maintain their normal daily routine, whether they are home or away on vacation, while their pacemakers maintain regular communication with the physician's office.

BIOTRONIK anticipates that both patients and physicians will benefit from Home Monitoring because of its ability to provide frequent, timely, concise cardiac information that is vital for effective cardiac rhythm management. Within minutes after the pacemaker's initial transmission, a Cardio Report is faxed directly to the physician's office. It includes graphic summaries of significant cardiac events, such as sustained ventricular tachycardia. It is anticipated that this information will allow specialists using Home Monitoring to be better informed, thereby helping them to respond more effectively to their patients' changing conditions.

A critical element of Home Monitoring is protecting the integrity of the patient's medical information and confidentiality as it travels though the worldwide communication network. To help ensure transmission success, Home Monitoring is the first commercial user of the Medical Implant Communication Service, a new government service regulated by the Federal Communications Commission. This new system provides a specific radio frequency (RF) bandwidth authorized solely for use by implanted medical products such as pacemakers and cardiac defibrillators. The dedicated RF bandwidth is free from environmental interference and provides an isolated pathway for Home Monitoring to transmit secure, uncorrupted digital information using radio frequency and cellular telephone technology anywhere in the world.

To further safeguard the integrity of the transmitted information, Home Monitoring uses multiple proprietary security and encryption protocols, as well as cyclical redundancy checks. Extensive electronic magnetic interference (EMI) and cellular telephone testing has proven that no interference occurs with the pacemaker's functionality during transmissions.

BIOTRONIK's Home Monitoring System is initially available in the company's dual-chamber, rate-responsive pacemakers with anticipated availability for cardiac defibrillators in 2002.

BIOTRONIK, Inc. is recognized worldwide as a complete provider of cardiovascular products of the highest quality and reliability. The company is committed to researching and developing new biomedical products. Its unmatched reliability record is the result of maintaining the highest standards in engineering and design. The company's U.S. headquarters is located in Lake Oswego, Oregon, and its worldwide headquarters is in Berlin, Germany.