BIOTRONIK, Inc. Announces FDA Approval and First U.S. Implant of Xelos DR-T Implantable Cardioverter Defibrillator.

PORTLAND, Ore. -- BIOTRONIK, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and first implant of a Xelos DR-T, the new high-energy ICD (Implantable Cardioverter Defibrillator). The device is part of a state-of-the-art system that incorporates Home Monitoring Early Detection technology, biphasic II shock capability, and 36-Joule shock energy.

"The FDA approval of our Xelos DR-T high-energy ICD represents another milestone in our drive to deliver complete tachycardia solutions to our customers," said Jake Langer, President of BIOTRONIK, Inc. "The combination of our exclusive Home Monitoring technology and 36-Joule shock capability will further increase safety and improve quality of care for our patients."

The first implant of the Xelos DR-T was performed at Maricopa Medical Center in Phoenix, AZ by Chief of Cardiology Edgardo Zavala-Alarcon, MD, FACC. The physician was impressed with BIOTRONIK's wireless remote monitoring technology, especially its ability to communicate the effectiveness of maximum output shocks in the rather vulnerable dilated cardiomyopathy patients whose ejection fraction is less than 30%. Dr. Zavala-Alarcon commented, "BIOTRONIK's Xelos DR-T combines a higher delivered energy with the revolutionary Home Monitoring feature, so that I can monitor and manage my patients' advancing disease."

Home Monitoring with Early Detection technology allows physicians to remotely monitor ICD patients on a real-time basis and quickly intervene when necessary. Events are automatically transmitted from the ICD to the Home Monitoring website, which provides access to patient and device data anytime, from anywhere. Early Detection technology immediately provides information on detection of arrhythmias, effectiveness of therapy, and system status.

BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Founded in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management companies, conducting business in over 100 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.