May 4, 2001
Guidant Announces First Implant of Ventricular Defibrillator Providing Advanced Atrial Therapies

PRIZM AVT Pulse Generator Receives European CE Mark Approval

Indianapolis, IN, and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a global leader in cardiac and vascular technology, today announced the first implant of its VENTAK PRIZM® AVT(tm) pulse generator, which is designed to treat arrhythmias that originate in either the upper or lower chambers of the heart.

The PRIZM AVT device received CE Mark approval from regulatory authorities in Europe on May 1. Guidant expects full market release in Europe in fourth quarter of 2001.

This new product leverages the science and intellectual property Guidant acquired in 1998 through its purchase of InControl Inc., Redmond, Wash., a technology company focused on atrial therapies. "These leading atrial therapy capabilities are a strong complement to Guidant's advanced pacing and defibrillation therapies that are delivered by the PRIZM AVT defibrillator," said Fred McCoy, president, cardiac rhythm management, Guidant Corporation.

The PRIZM AVT product incorporates advanced diagnostics and therapies for both atrial and ventricular arrhythmias. In addition to the extensive diagnostics included in Guidant's PRIZM family of products, the PRIZM AVT technology provides the following therapeutic capabilities:

  • Atrial Rhythm Classification, a sophisticated method of discriminating between two atrial arrhythmias - atrial flutter and atrial fibrillation - to help ensure proper therapy delivery.

 

  • Ventricular Rate Regulation, a pacing algorithm designed to reduce the variability in ventricular rate during atrial fibrillation.

 

The first human use of the new system - the PRIZM AVT pulse generator and the PERIMETER? CS lead designed to direct energy to the upper chambers of the heart - took place on May 2 at S. Orsola Bologna Hospital, Bologna, Italy. Mauro Biffi, M.D., implanted the system in a 64-year-old man suffering from ischemic dilated cardiomyopathy and paroxysmal atrial fibrillation. Ischemic dilated cardiomyopathy is an enlargement of the heart caused from insufficient oxygen flow to the heart muscle. The condition may damage the heart's electrical conduction system, resulting in arrhythmias. A European field following protocol will now begin under the direction of principal investigator Guiseppe Boriani, M.D.

"The European approval for the PRIZM AVT product is another affirmation that Guidant is a leader in providing solutions for a wide range of cardiac arrhythmias and heart failure," said Guido Neels, president, Europe, Middle East, Africa and Canada, Guidant Corporation. "PRIZM AVT will add to our family of therapeutic solutions in Europe for treatment of cardiac morbidities, such as the PULSAR(tm) MAX II pacemaker and our CONTAK CD(tm) cardiac resynchronization therapy for heart failure."

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

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