FDA Panel Considers Over-The-Counter Home Defibrillator.

GAITHERSBURG, Md. -- Sudden cardiac arrest (SCA) is a leading cause of death in the United States--claiming 340,000 lives a year. However, the current cardiac arrest survival rate is less than five percent, largely because defibrillators do not reach victims in time. For each minute that passes before defibrillation therapy is administered, the chance for survival decreases by about 10 percent.

The majority of cardiac arrests--nearly 80 percent--occur in the home and more than half are witnessed by someone who could help. On Thursday, July 29, 2004, a U.S. Food and Drug Administration (FDA) panel will discuss an application to remove the prescription requirement for the HeartStart Home Defibrillator. The 510(k) submission sponsor is Philips Medical Systems, a division of Royal Philips Electronics. Philips has requested over-the-counter (OTC) clearance of its HeartStart Home Defibrillator to increase access to potentially life-saving technology in the home.

Cleared by the FDA in November 2002, the HeartStart Home Defibrillator is the first new-generation defibrillator specifically designed for use in the home. It is the only defibrillator that will be discussed for OTC use by the FDA Medical Devices Advisory Committee.

Who:   U.S. Food and Drug Administration Circulatory System
          Devices Panel

   What:  HeartStart Home Defibrillator OTC Clearance

   When:  July 29, 2004
          9:00 AM - 5:00 PM

   Where: Holiday Inn, Grand Ballroom
          Two Montgomery Village Ave.
          Gaithersburg, MD

For additional information contact: Jayme Maniatis or Dana Conti of Schwartz Communications, ph. 781-684-0770 or Graeme Slattery of Philips Electronics North America, ph. 212-536-0872.

A photo of the HeartStart Home Defibrillator follows this advisory.

A satellite feed which includes a demonstration of the HeartStart Home Defibrillator, an interview with a cardiac arrest survivor and a physician who is presenting to the panel will be available.

SATELLITE FEED INFORMATION:

FEED DATE: Friday July 30, 2004

FEED TIME: 10:45am-11:15am EDT (Dedicated)

COORDINATES: AMC3 / Transponder 4 C-band

DOWNLINK FREQ: Downlink: 3780 Vertical

RE-FEED DATE: Friday July 30, 2004

RE-FEED TIME: 1:45pm-2:15pm EDT (Dedicated)

COORDINATES: IA6 / Transponder 24 C-Band

DOWNLINK FREQ: Downlink: 4180 Horizontal

RE-FEED DATE: Monday August 2, 2004 (fed in rotation)

RE-FEED TIME: 10:00am-10:30 EDT (Dedicated)

COORDINATES: IA6 / Transponder 22 C-band

DOWNLINK FREQ: 4140 Horizontal

Produced for Philips Medical Systems.

For satellite feed technical information, contact: Award Productions, ph. 978-667-3335.