Apr 30, 2001
Guidant Announces First Implant of Next Generation Heart Failure Device

Heart Failure Technology Deemed Fileable on an Expedited Basis

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT) today announced the first implant of the CONTAK RENEWAL(tm) system, its most advanced heart failure therapy system currently under investigation anywhere in the world.

The CONTAK RENEWAL device contains new diagnostic capabilities that are designed to help physicians better manage their patients' condition by capturing information that is relevant to physician decision-making. The device monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. Also, CONTAK RENEWAL uses data from an accelerometer sensor to track trends in patients' activity levels. This capability addresses heart failure physicians' desire to monitor activity levels as an indication of their patients' ability to perform activities of daily living.

Raymond Yee, M.D., director of arrhythmia services at London Health Science Center, London, Ontario, Canada, performed the first implant of the device on April 30. The patient was a 72-year-old woman suffering from idiopathic dilated cardiomyopathy, an enlargement of the heart of undetermined origin that negatively affects the heart's pumping ability and may damage the heart's electrical conduction system. The CONTAK RENEWAL device provides cardiac resynchronization therapy, which is designed to enhance pumping function, and defibrillation capability. Defibrillation therapy has been shown through numerous studies to prevent sudden cardiac death caused by dangerous heart rhythm disturbances.

Guidant will present the results of a clinical trial of its CONTAK CD cardiac resynchronization therapy defibrillators on May 2 at a symposium held in conjunction with the 22nd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology (NASPE) in Boston. This information formed the basis for Guidant's pre-market approval (PMA) filing with the U.S. Food and Drug Administration (FDA) for the CONTAK/EASYTRAK® product family.

FDA has completed an initial review of Guidant's PMA and determined that the PMA is sufficiently complete and suitable for filing. In a letter to Guidant, FDA has said, "We are also pleased to inform you that your application will receive expedited processing. Expedited review status was gained because the availability of the device is in the best interest of the patients."

"We are encouraged by the prospect of providing timely availability of this significant therapy for patients," said Fred McCoy, president, cardiac rhythm management, Guidant Corporation.

A global leader in the medical device industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.