Market Release of BIOTRONIK Pacemaker Featuring a Physiologic Rate-Adaptive Algorithm and Wireless Transmissions for Arrhythmia Monitoring and Event Notification.

LAKE OSWEGO, Ore. -- Closed Loop Stimulation (CLS)(R) Rate-Adaptive Technology Enables a Physiologic Response to Patient Metabolic Demands Including Acute Mental Stress

BIOTRONIK today announced that the first U.S. implantation of a Cylos DR-T pacemaker took place at the Fuqua Heart Center of Piedmont Hospital in Atlanta, GA. The surgical procedure was performed by Bobby A. Smith, MD, Electrophysiologist, Co-Director of the Electrophysiology Lab. The Cylos pacemaker family has recently been approved by the U.S. Food and Drug Administration (FDA), marking the debut of one medical device containing two unique BIOTRONIK technologies: Closed Loop Stimulation (CLS)(R) and Home Monitoring(R) Early Detection.

The significance of this marriage of technologies is that physicians no longer have to choose between enhanced clinical management (Home Monitoring) and improved quality of life for patients (CLS). Patients who receive a Cylos DR-T can now benefit from the most physiologic rate-adaptive system on the market -- the only system capable of responding to more than just exercise demands -- while being virtually linked to their physician in case of arrhythmias, changes in device status (i.e. battery voltage or lead impedance), or other significant cardiac events.

CLS is the only pacemaker technology that has demonstrated the ability to respond to acute mental stress -- a non-exercise autonomic stressor. For the majority of pacemaker patients, this technology promises to provide a significant improvement in quality of life, because CLS is designed to translate signals sent from the autonomic nervous system, namely myocardial contractility, and provide an appropriate heart rate in response to the many activities of daily living.

Thomas Brown, Executive Vice President for BIOTRONIK, Inc., stated, "Cylos DR-T is the world's only cardiac pacemaker to offer the unique and proprietary rate-adaptive algorithm known as Closed Loop Stimulation, which can respond to both acute mental stress and physiologic demands, essentially mimicking the heart's natural response mechanism. Teamed with the patient care benefits of Home Monitoring Early Detection, BIOTRONIK's automatic, remote patient monitoring system, CLS provides physicians the ability to improve patient outcomes and greatly simplify and automate patient follow-up."

Home Monitoring automatically transmits intracardiac events via wireless technology allowing the physician to view vital patient information on a secure website at anytime, from anywhere, within minutes of the event occurring. In the instance of a cardiac event such as an atrial arrhythmia, the wireless system incorporated in the Cylos DR-T pacemaker will automatically and immediately transmit this record to the physician's office without requiring any patient involvement.

The clinical value of CLS and the prompt remote reporting capability is represented by Dr. Smith: "CLS is an algorithm that supplies patients with the physiologic rate appropriate for their hemodynamic needs, even in the case of mental stress. This algorithm is easy to use and requires little maintenance as it automatically adjusts to changing trends according to varying patient activity and drug regimes. Home Monitoring is invaluable for several reasons: recording of what would otherwise be difficult-to-detect arrhythmia episodes, immediate notification of severe events such as lead dislodgement and device end-of-service, as well as maintenance of a database of events and device trends. While CLS appropriately responds to the mental stress of the patient, Home Monitoring reduces the mental stress of the physician."

BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Started in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management (CRM) companies, conducting business in over 60 countries worldwide and providing a full range of innovative cardiovascular products of the highest quality and reliability. BIOTRONIK has pioneered many innovative technologies, including Closed Loop Stimulation and Home Monitoring, which provides real-time early detection of arrhythmias and disease progression through proprietary wireless technology. BIOTRONIK's motto, "Technology Helping to Heal," is reflected in the company's primary guiding principle: helping patients by researching, developing, and marketing biomedical products to restore, secure, and enhance their quality of life.