BIOTRONIK Announces FDA Approval of the Tachos ATx ICD with Atrial Therapies.

Business Editors & Health/Medical Writers

PORTLAND, Ore.--(BUSINESS WIRE)--May 29, 2003

Second-Generation System Offers the Most Effective Device-Based,

Painless Therapy Available for the Treatment of Atrial Arrhythmias

BIOTRONIK, Inc. announced today U.S. Food and Drug Administration (FDA) approval of the Tachos ATx implantable cardioverter defibrillator (ICD). The Tachos ATx ICD system is BIOTRONIK's second-generation device that offers the most effective atrial therapies available in the industry today. With its unique array of clinically proven features, the Tachos ATx helps physicians completely manage both atrial and ventricular arrhythmias in their ICD patients.

Atrial fibrillation is the most common heart rhythm disorder, affecting approximately 2.3 million Americans. It is estimated that at least 30 percent of the over 80,000 annual ICD recipients have some type of atrial arrhythmia at the time of implantation, with that number increasing to nearly 50 percent at device replacement (typically five years). Atrial arrhythmias pose a serious health problem for the patient and are known to be associated with an increased risk of stroke, advancements in heart failure, and a doubling of mortality. Studies have also shown that many AF patients experience a significant reduction in quality of life, exercise tolerance, and overall cardiac performance. New treatment options available in the Tachos ATx device offer the physician the flexibility to monitor, discriminate, and treat the progression of recurring atrial tachyarrhythmias.

The Tachos ATx ICD represents BIOTRONIK's commitment to offering the most advanced combined arrhythmia management features possible. The device provides multiple options for terminating atrial arrhythmias, including ATP, HF burst, and cardioversion therapy. As demonstrated in the TACT (Tachos Atrial Conversion Therapy) clinical study, HF burst therapy proved to be the industry's most effective painless therapy for the treatment of AF-detected episodes. In fact, BIOTRONIK's HF burst therapy was shown to be more than twice as effective in terminating AF episodes when compared to similar atrial therapy schemes currently available in competitive devices. Patients' quality-of-life indicators also showed significant improvement with the frequency and severity of patients' symptoms being reduced by nearly 40 percent.

"Being able to treat a patient's atrial arrhythmias with the Tachos ATx HF Burst therapy is a nice alternative to shock therapy and oftentimes goes completely undetected by the patient," explained Lawrence Gering, M.D. of Owensboro Mercy Health System in Owensboro, KY.

The Tachos ATx ICD also includes BIOTRONIK's proprietary SMART Detection(TM) dual-chamber discrimination algorithm, the industry's most effective arrhythmia discriminator with a clinically proven sensitivity/specificity of 100 percent and 94 percent, respectively. Other competitive features include 32 minutes of stored, dual-channel electrograms, accelerometer-based, rate-adaptive pacing, back-up pacing for all atrial therapies, mode switching, and an extensive diagnostic package.

BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Started in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management companies, conducting business in over 60 countries worldwide, and providing a full range of innovative cardiovascular products of the highest quality and reliability. BIOTRONIK's motto, "Technology Helping to Heal," is reflected in the company's primary guiding principle: helping patients by researching, developing, and marketing biomedical products to restore, secure and enhance their quality of life.