BIOTRONIK Receives Approval for the Tachyarrhythmia Monitoring System, TMS 1000.

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Nov. 11, 1998--Biotronik Inc. announced today the approval by the U.S. Food and Drug Administration (FDA) of the TMS 1000 (Tachyarrhythmia Monitoring System) programmer.

The TMS 1000 is the market's first comprehensive patient management system for the implantation, testing and follow-up of ICD systems.

Weighing less than 13 pounds, the TMS 1000 is a Windows-based, compact, portable system with all critical components integrated into a single device. The TMS 1000 was primarily designed to be used with BIOTRONIK's Phylax family of ICDs. The TMS 1000 includes a pacing system analyzer (to evaluate pacing and sensing functions), three induction programs (to assess defibrillation thresholds), 40 joule rescue capability and a full-featured programmer capable of performing device-based testing. The physician's entire troubleshooting and standard follow-up capabilities are performed easily through the TMS 1000.

The touch screen of the TMS 1000 facilitates easy movement through the programmer menus. The TMS 1000 is capable of displaying real-time IEGMs along with an ECG and marker channel that easily prints for documentation purposes. All of the Phylax's stored data is rapidly accessed and then formatted for printing via the TMS 1000's high-speed printer.

The state-of-the-art TMS 1000 provides physicians with a complete and comprehensive programmer for the testing and follow-up of the Phylax ICD system. Designed to be small, portable and easy to use, the TMS 1000 will establish a new standard with respect to ease of use and time saving.

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 are located in Lake Oswego, Oregon, with worldwide headquarters in Berlin, Germany.