BIOTRONIK Announces the First Implantation of Implantable Cardioverter Defibrillator with Cardiac Resynchronization and Atrial Tachyarrhythmia Therapies.

Business Editors/Health/Medical Writers

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Nov. 13, 2003

BIOTRONIK, Inc. announced today the first US implantation of a unique implantable cardioverter defibrillator (ICD) that provides three essential therapies in a single device: cardiac resynchronization therapy (CRT) for treating heart failure, atrial therapy for atrial tachyarrhythmias, and ICD therapy for ventricular tachyarrhythmias.

Dr. Kyong Turk performed the first implantation of this breakthrough ICD system at Nebraska Heart Institute in Lincoln, Nebraska, in an 84-year-old patient with advanced heart failure. Dr. Turk stated, "CRT, in general, is an expensive form of therapy. If an implantable device can reduce AF burden, we can obtain more benefit from CRT. The BIOTRONIK Tupos LV/ATx is a novel device that provides a range of therapies to treat a variety of cardiac disorders. As a result, the implanted device becomes a more cost-effective form of therapy." This patient was enrolled in BIOTRONIK's latest investigational study aimed at evaluating the benefits of these combined therapies. Previous CRT studies have demonstrated improvements in quality of life and functional measures for patients with advanced congestive heart failure (CHF). As a result, ICD's with CRT currently account for about one third of the ICD implants in the United States as well as the recent, substantial growth in the ICD market.

CHF and atrial tachyarrhythmias are closely interrelated diseases with similar risk factors. Approximately one-third of all ICD patients develop atrial tachyarrhythmias, and about 40% of patients with CHF develop atrial tachyarrhythmias. Episodes of atrial tachyarrhythmias can have more serious consequences on patients implanted with CRT devices, because CRT requires continuous ventricular pacing. During an episode of atrial tachyarrhythmias with fast conduction, ventricular pacing (and therefore CRT) might be withheld from a patient. Maintenance of normal sinus rhythm is very important for patients with advanced heart failure, limited functional capacity, and a low ejection fraction. Dr. Turk further commented, "Approximately 30% of patients implanted with CRT devices can have episodes of atrial fibrillation, which compromise cardiac resynchronization therapy, particularly when patients have a fast ventricular response."

The atrial tachyarrhythmia conversion features included in this CRT device were previously evaluated in BIOTRONIK's TACT (Tachos Atrial Conversion Therapy) clinical study. The TACT study evaluated patients with standard ICD indications as well as a history or significant risk of atrial tachyarrhythmias. The device successfully converted nearly 60% of the spontaneous atrial tachyarrhythmia episodes in this study. Most importantly, the BIOTRONIK ICD's offer multiple options to terminate atrial arrhythmias including atrial antitachycardia pacing (ATP), high-frequency burst, and automatic atrial cardioversion therapy. The atrial high frequency burst pacing therapy converted approximately 40% of atrial tachyarrhythmia episodes, a success rate that is substantially higher than any other available device. Patient quality-of-life measurements were also significantly improved following device implantation in this previous study. Previously published research has demonstrated that atrial electrical remodeling occurs within 24 to 48 hours following the onset of an atrial tachyarrhythmia. The longer these arrhythmias are allowed to persist, the more difficult it is to return the patient to normal sinus rhythm.

BIOTRONIK is initiating this clinical study at over 30 centers in the U.S. and will enroll approximately 200 patients. The study design is unique because it compares the clinical benefits of CRT in patients implanted with the BIOTRONIK CRT-ICD to the benefits of CRT in patients implanted with market-released CRT-ICDs from two other companies, Guidant and Medtronic, without atrial therapy. Unlike previous CRT studies, all patients will receive CRT for the entire duration of the clinical study. BIOTRONIK expects to complete study during 2004.

BIOTRONIK, a world leader in the cardiovascular device industry, is committed to the research and development of new biomedical products. The company's US headquarters are located in Lake Oswego, Oregon, with worldwide headquarters in Berlin, Germany.