FDA Clears the Philips HeartStart Home Defibrillator for Over-the-Counter Sale

Business Wire, Sept 16, 2004

ANDOVER, Mass. -- Royal Philips Electronics today announced U.S. Food and Drug Administration (FDA) clearance of the HeartStart Home Defibrillator for sale without a prescription. The FDA's decision follows the favorable consensus of the Circulatory System Devices Panel, which met on July 29, 2004 and supported removing the prescription requirement. Defibrillators provide therapy for the most common cause of sudden cardiac arrest (SCA), a leading cause of death among adults in the U.S. The Philips HeartStart Home Defibrillator was the first new-generation defibrillator specifically designed for home use. It is now the first defibrillator cleared for over-the-counter sale, a move that will help make the HeartStart Home Defibrillator more easily available to consumers for home use, where the majority of cardiac arrests occur.

"It is important to recognize that for a substantial percentage of SCA victims, cardiac arrest is the first sign of heart disease," said Dr. Jeremy Ruskin, Director of the Cardiac Arrhythmia Service at Massachusetts General Hospital. "We know that access to early defibrillation helps save lives. Removal of the prescription requirement for the HeartStart Home Defibrillator gives people freedom of choice to be better prepared for unexpected cardiac arrest--a rare but life threatening emergency."

Sudden cardiac arrest is a leading cause of death in the United States, claiming approximately 340,000 lives each year. Defibrillators provide treatment for ventricular fibrillation, the most common cause of sudden cardiac arrest. For each minute that passes before defibrillation therapy is administered to a victim, the chance for survival decreases by about 10 percent. It takes an average of nine minutes for emergency professionals to reach a victim in a typical community.

In recent years, communities, businesses and schools have deployed defibrillators in an effort to improve survival from sudden cardiac arrest. Published studies show that survival rates can increase dramatically when defibrillators are deployed in public places. While the majority of cardiac arrests occur in the home, the chance of survival can be less than half the chance of survival in public places. At the recent Circulatory System Devices panel meeting, physicians, professional organizations and cardiac arrest survivors concurred that greater access to defibrillators will help save lives from what is often a treatable, yet unpredictable, emergency.

Cleared by the FDA in 2002 for sale by prescription, the HeartStart Home Defibrillator was the first new-generation defibrillator designed specifically for use in the home. Patented technologies and an award-winning design make it fast to learn and easy to use. Designed around the user, the HeartStart Home Defibrillator provides clear, calm voice instructions that guide responders through every step of the defibrillation process, even reminding them to call for emergency help and providing CPR coaching. In addition, advanced SMART Pad technology senses the responder's actions with the pads and automatically adjusts the pace of the voice instructions to meet the individual responder's needs. Patented voice coaching for adult and infant/child CPR provides audio cues for each breath as well as the appropriate number and rate of chest compressions. Daily self-tests of multiple system components, including a check for pads readiness, renders the device virtually maintenance free. A loud chirp alerts family members when any part of the system needs attention. Specially designed infant/child pads make the HeartStart Home Defibrillator appropriate for use on infants and children under the age of 8 or weighing less than 55 lbs. This Infant/Child SMART Pads cartridge will continue to be available by prescription.

"The HeartStart Home Defibrillator was designed to help virtually anyone use this life-saving technology," said Deborah DiSanzo, vice president and general manager for cardiac resuscitation at Philips Medical Systems. "The FDA's decision will help accelerate our vision of making defibrillator technology broadly accessible to help save lives that would otherwise be lost to sudden cardiac arrest."

The HeartStart Home Defibrillator, along with an owner's manual and instructional video, is available to consumers by calling 1.866.DEFIBHOME (1.866.333.4246) or by visiting www.HeartStartHome.com. The price is $1,995 (U.S.). Consumers interested in learning more about sudden cardiac arrest and the need for early defibrillation, sharing experiences, or locating a CPR training program in their area can visit www.HeartStartHome.com.

For further information please contact:
   USA:          Heidi Wilson, Philips Medical Systems
                 Tel:  1 978 659 7302
                 heidi.wilson@philips.com

                 Steve Kelly, Philips Medical Systems
                 Tel:  1 425 487 7479
                 steve.kelly@philips.com

                 Jayme Maniatis or Dana Conti for Philips Medical
                 Systems
                 Tel:  1 781 684 0770
                 philips@schwartz-pr.com

SATTELITE FEED INFORMATION:
FEED DATE:       Thursday, September 16, 2004
FEED TIME:       3:30-3:45 PM ET (Dedicated)
COORDINATES:     C Band: IA (formerly Telstar) 6 (C)/Transponder
                 15/Audio 6.2 & 6.8
DL:              4000 (V)

RE-FEED DATE:    Thursday, September 16, 2004
RE-FEED TIME:    7:00-7:45 PM ET (Dedicated)
COORDINATES:     C Band: IA (formerly Telstar) 6 (C)/Transponder 15
                 /Audio 6.2 & 6.8
DL:              4000 (V)

RE-FEED DATE:    Friday, September 17, 2004
RE-FEED TIME:    10:45-11:00 AM ET (Dedicated)
COORDINATES:     C band: IA (formerly Telstar) 6 (C) /Transponder 16
                 /Audio 6.2 & 6.8
DL:              4020 (H)

RE-FEED DATE:    Friday, September 17, 2004
RE-FEED TIME:    1:45 - 2:00 PM ET (Dedicated)
COORDINATES:     C Band: IA (formerly Telstar) 6 (C) /Transponder 16
                 /Audio 6.2 & 6.8
DL:              4020 (H)