Aug 8, 2000
Guidant Announces FDA Approval of PRIZM 2

World''s Smallest, Most Advanced, Dual-Chamber Implantable Defibrillation System

Indianapolis, IN, and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT) today announced the company has received FDA approval to market the world's smallest, thinnest, dual-chamber pacemaker/defibrillator - the VENTAK® PRIZM(tm) 2 AICD automatic implantable cardioverter defibrillator system.

The VENTAK PRIZM 2 system is designed to treat patients at risk of life-threatening ventricular heart rhythms. 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 2 device is implanted under the skin near the collarbone to continuously monitor the patient''s heart rhythm and deliver therapy when needed.

"We are delighted with the FDA approval to market the VENTAK PRIZM 2 system and plan to launch worldwide in the fourth quarter of this year," said Fred McCoy, president of Guidant''s Cardiac Rhythm Management Group. "The launch of VENTAK PRIZM 2 will give our customers access to the smallest, thinnest, longest lasting, and easiest to use technology. The VENTAK PRIZM 2 system demonstrates Guidant''s engineering capability and commitment to continue to deliver medical solutions that lead the industry in providing real benefits to patients.

"We expect VENTAK PRIZM 2 to build on the success of the VENTAK PRIZM system we launched in February this year," McCoy continued. Guidant sales of implantable defibrillators in the U.S. set a new company record in second quarter 2000, with growth of 30 percent versus the second quarter of 1999.

In addition to its small physiologic shape - 32 cc in size and 12 mm thin - the VENTAK PRIZM 2 product also offers physicians and their patients unmatched device longevity. Guidant, dedicated to promoting cost-effective ICD therapy, has engineered the system to outlast competitors'' similarly sized dual-chamber devices by a factor of years.

"With its small, thin shape and outstanding longevity, the VENTAK PRIZM 2 is designed for maximum patient comfort and convenience," commented Helmut Klein, M.D., professor of medicine and head of the division of cardiology at the University Hospital of Magdeburg in Magdeburg, Germany.

The VENTAK PRIZM 2 system is focused not only on managing complex arrhythmias, but also on saving clinicians'' time by enabling them to make better decisions faster. The new ease-of-use tools automatically collect, store and display important patient data, allowing the busy clinician convenient access to critical information. The system also allows quick diagnosis of arrhythmias in the upper and lower chambers of the heart through on-screen stored electrograms. This information allows the clinician to adjust the patient''s treatment if needed.

The VENTAK PRIZM 2 instantly stores cardiac data during symptomatic episodes with a Patient Triggered Monitor. With this feature, a patient experiencing symptoms can initiate storage of heart rhythm activity for later evaluation.

"VENTAK PRIZM 2 will leverage the capabilities of the recently released ZOOM(tm) Programming System which has received extraordinary reviews for its speed and performance since its introduction a week ago," stated Fred McCoy. "This is a very exciting time for Guidant as we redefine the standard in implantable defibrillator technology by continuing to make implants and patient follow-ups faster and easier."

The VENTAK PRIZM 2 product is the sixth in a series of sophisticated, full-featured, dual-chamber pacing and defibrillation devices introduced by Guidant since September 1996.

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.