BIOTRONIK Announces FDA Approval of the Tachos DR-Atrial Tx Implantable Cardioverter Defibrillator.

Business Editors, Health/Medical Writers

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Sept. 9, 2002

BIOTRONIK, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the commercial release of the Tachos DR -- Atrial Tx Implantable Cardioverter Defibrillator (ICD).

This approval represents a major milestone placing BIOTRONIK at the forefront of the growing dual-chamber therapy ICD market. With this release, BIOTRONIK becomes one of only two companies in the United States to provide atrial therapies in a dual-chamber ICD.

In addition to providing effective ventricular therapy, Tachos DR-Atrial Tx features multiple options to terminate atrial arrhythmias including pacing, high-frequency burst and shock therapy in AT and AF detection zones. As demonstrated in the TACT (Tachos Atrial Conversion Therapy) Clinical Study, the device painlessly converts arrhythmias with high-frequency burst therapy in over 43% of atrial fibrillation episodes - a substantially higher success rate than achieved by any other commercially available device. Patient quality-of-life indicators with the Tachos DR-Atrial Tx also showed significant improvement at just three months post-implant. Atrial therapies have won wide acceptance among patients, with 89% of patients having atrial therapy active at last follow-up.

"By providing an effective, painless method of terminating Afib, the Tachos DR-Atrial Tx ICD promises to be of great clinical benefit to a wide range of patients," explained Richard Borge, M.D., St. Francis Medical Center, Trenton, N.J., in reference to high-frequency therapy.

The new device is designed for patients that require therapy for the treatment of life-threatening ventricular tachyarrhythmias with coexisting atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias. With up to 32% of all ICD recipients developing atrial tachyarrhythmias, these indications suggest that tens of thousands of patients may benefit from an ICD with atrial therapies.

The Tachos DR -- Atrial Tx ICD offers a full feature set, including SMART Detection(TM), one of the most sophisticated and effective detection algorithms available for the discrimination of ventricular tachycardias and supraventricular tachycardias. Other competitive features include 32 minutes of stored, fully annotated, dual-chamber stored heart rhythm recordings (IEGMs), accelerometer-based rate-adaptive pacing, back-up pacing for all atrial therapies, Mode Switching and an extensive diagnostic package.

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 results from maintaining the highest standards in engineering and design. The company's U.S. headquarters are located in Lake Oswego, Ore., and its worldwide headquarters are in Berlin, Germany.