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First Implantation of an ICD with Mobile Online Remote Monitoring   press release 12/21/01

The BIOTRONIK Home Monitoring System Automatically Sends Diagnostic Data from the Implant to the Physician

BERLIN--(BUSINESS WIRE)--Dec. 21, 2001--BIOTRONIK has announced the first ever implantation of an implantable cardioverter-defibrillator (ICD) with mobile remote data transmission.

The Belos VR-T is equipped with a transmitter that automatically sends diagnostic data to the attending physician via the BIOTRONIK Home Monitoring System. The data is transmitted through a cell phone-like patient device over the GSM network to a Service Center. There the data are analyzed automatically and the physician is notified immediately in case of an emergency.

Cardiac surgeon Dr. Francis Wellens performed the implantation at the OLV Clinic in Aalst, Belgium, on December 20, 2001. The 65-year-old patient, selected by Professor Pedro Brugada, M.D., suffers from sustained ventricular tachycardia postmyocardial infarction. The patient received the Belos VR-T to treat his arrhythmias and prevent sudden cardiac death.

The Belos VR-T's Home Monitoring function was activated post-operatively, and two minutes later Professor Brugada received the first report regarding his patient's status, a so-called ``Cardio Report.'' The Cardio Report contains the most important data about the frequency and effectiveness of therapy-relevant events as well as information regarding the technical status of the implant's functions. Therefore, the patient's condition can be monitored even after being discharged from the hospital. ``Therapy management of ICD patients has been revolutionized by this system,'' says Professor Brugada. ``Thanks to the information in the Cardio Report, we can decide on further diagnostic steps, such as quickly scheduling a patient for a follow-up visit.''

Belos VR-T initiates data transmission automatically; the patient does not need to do anything. The mobile patient device can be used at home or when a patient is away. When no unusual events occur, periodic data concerning the patient's cardiac condition and the implant's status are transmitted once daily. The physician sets the time of data transmission for each patient individually according to his or her wishes. If therapy-relevant events take place, the data is transmitted immediately. The Cardio Reports generated in the Service Center provide the physician with an overview of current and previous readings. ``Analysis of these daily readings will bring new scientific insights into our understanding of and therapy for complex cardiac symptoms,'' says Professor Brugada.

BIOTRONIK is already approved to sell pacemakers with mobile online remote monitoring in the U.S. and Europe; now it has expanded the new Home Monitoring technology to include the ICD field. Belos VR-T is CE-certified and will be evaluated next year in an international, multicenter study under the direction of Professor Brugada. The study will research new possibilities in the therapy management of ICD patients with the aid of mobile online data transmission.

BIOTRONIK is a leading international manufacturer of medical technology, specializing in electrotherapy of the heart and vascular intervention. The company operates in over 60 countries and employs more than 2,300 people worldwide.
     BIOTRONIK GmbH & Co.
     Dr. Hans-Jurgen Wildau, Director of Health Services       +49-30-68905-332        www.biotronik.de

More from company at: http://www.biotronik.de/content/detail.php?id=1249