BIOTRONIK Announces First Investigational Implant of the Tachos DR ICD with Atrial Therapy

Business Wire, Dec 22, 2000

Business Editors

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Dec. 22, 2000

Biotronik, Inc. announced today the first investigational implant of the Tachos DR ICD with Atrial Therapy.

This device represents a significant milestone in the treatment of arrhythmias in both the atrium and ventricle. The Tachos DR ICD with Atrial Therapy is the first device implanted in the US with the ability to treat both atrial and ventricular arrhythmias while providing rate-adaptive pacing therapy for the patient. Dr. Larry Gering performed the implantation at Owensboro Mercy Hospital in a patient with a history of paroxysmal atrial fibrillation and ventricular tachyarrhythmias. Biotronik, Inc. is sponsoring this Phase I IDE in 15 US centers to collect the necessary data to support the eventual PMA approval of this device.

The Tachos DR ICD with Atrial Therapy features SMART Detection(TM), a clinically proven algorithm for the discrimination of ventricular and supraventricular tachycardias. Designed to increase specificity while maintaining sensitivity, SMART Detection demonstrated 94% specificity while maintaining 100% sensitivity in clinical trials of the Phylax AV. The ability to properly discriminate the origin of arrhythmias is crucial for appropriate treatment of the arrhythmia. This device provides multiple detection and therapy options for the detection and treatment of both atrial and ventricular arrhythmias. The device is able to provide both pacing and shock therapies for the treatment of atrial or ventricular arrhythmias.

The Tachos DR with Atrial Therapy provides an extensive array of diagnostic capabilities to include 32 minutes of high fidelity, dual-chamber heart rhythm recordings (IEGMs). Other competitive features include SMART Success IEGM storage, Mode Conversion with programmable ventricular rate support, a PMT termination algorithm, Real-time IEGMs to facilitate troubleshooting and programming, along with a sophisticated EP Test Mode to evaluate defibrillation therapy thresholds and the efficacy of anti-arrhythmic drug therapy in both chambers.

The implantation of the Tachos DR ICD with Atrial Therapy provides a unique solution to those patients who have, or may develop, atrial arrhythmias along with their ventricular arrhythmias. This device continues Biotronik's commitment to providing biomedical products that meet the clinical needs of physicians and patients.

BIOTRONIK, a world leader in the cardiovascular device industry, is committed to researching and developing new biomedical products. The company's North American headquarters is located in Lake Oswego, Oregon, with worldwide headquarters in Berlin, Germany.