Aug 9, 2000
Guidant Announces FDA Approval to Market VENTAK PRIZM HE System

Indianapolis, IN, and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a worldwide leader in implantable defibrillation systems, today announced the company has received FDA approval to market a new high-output dual-chamber defibrillation system for patients with high defibrillation thresholds. Called the VENTAK® PRIZM(tm) HE system, this product is the only one in the industry to provide both a size and output advantage.

"For those rare cases where high output was required, I previously needed to choose between size and output," noted Thomas S. Ahern, MD, Director of Electrophysiology at University Medical Center and Sunrise Hospital in Las Vegas, Nevada. "With the introduction of the PRIZM HE, I now can offer those patients a device that is small and capable of high output."

"By rapidly expanding the number of VENTAK PRIZM implantable defibrillator systems, Guidant now offers clinicians a complete family of technology choices that is unequalled in the industry," noted Fred McCoy, president of Guidant''s Cardiac Rhythm Management group. "The entire family - VENTAK PRIZM 2, VENTAK PRIZM HE and VENTAK PRIZM - is smaller than the 40 cc benchmark, therefore, physicians are now in a position to chose the appropriate system for each patient without compromise."

The VENTAK PRIZM HE is a continuation of Guidant''s leadership in implantable defibrillation technology. Just yesterday, Guidant announced that it had received FDA approval to market its VENTAK PRIZM 2 system - the world''s smallest, thinnest, dual-chamber pacemaker/defibrillator.

The VENTAK PRIZM HE product provides physicians and their patients the same small, physiologic shape and full feature set as the VENTAK PRIZM system, but with 41 J of stored energy. Guidant is the only company in the industry to present customers with this unique implant option which provides both a size and output advantage.

Patients with fast heart rhythms can experience symptoms such as palpitations, dizziness, lightheadedness, fainting or near fainting if the heart beats too fast to circulate blood effectively. Collapse and sudden cardiac death can follow unless medical help is provided immediately. The VENTAK PRIZM HE device is implanted under the skin near the collarbone to continuously monitor the patient''s heart rhythm and deliver therapy when needed for patients at risk of life-threatening ventricular heart rhythms.

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