U.S. FDA Clears Philips Home Defibrillator
November 2002
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Philips Electronics today said the U.S. Food and Drug Administration (FDA) gave clearance for its HeartStart Home Defibrillator, the first defibrillator for home use.

Defibrillators provide treatment for sudden cardiac arrest (SCA), a leading cause of death in the U.S., which is said to claim a quarter million lives each year. Philips says published studies show over 70 percent of arrests happen in the home and the majority of those are witnessed.

The Philips HeartStart Home Defibrillator was researched and designed for ease of use and is said to be ideal for the emerging class of home responders who want to be able to help save the lives of friends and relatives in the event of cardiac arrest.

While many ambulances are equipped with defibrillators that could help a cardiac arrest victim in the home, Philips says therapy must be delivered within minutes for survival, while in a typical community it takes an average of 9 minutes for an ambulance to reach a victim. For each minute that passes, the chance for survival decreases by about 10 percent, the company explains.

"This is a potentially valuable approach to the prevention of death from sudden cardiac arrest," said Dr. Gust H. Bardy, clinical professor of medicine, attending physician, University of Washington Medical Center, Seattle, Washington. "Defibrillation within the first few minutes of collapse from the cardiac rhythm problem called ventricular fibrillation, the most common cause of cardiac arrest, can be a very effective therapy with this often unpredictable and tragic event. Because the majority of cardiac arrests occur in the home, the development of an AED specifically for home use by nearby family members is a logical progression of the technology."

The underlying defibrillation technology of the HeartStart is identical to the more than 100,000 Philips automated external defibrillators (AEDs) in use on airlines, and in airports, workplaces, and communities across the globe. However, the home-use unit features additional patented technologies and design refinements to make it fast to learn and easy to use.

  • Clear, calm voice instructions - more comprehensive than those offered by AEDs used by trained first responders - guide an operator through every step of the defibrillation process, even reminding them to call for emergency help and providing CPR coaching.

  • 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 voice instructions and 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, is said to render the device virtually maintenance free.

  • A loud chirp alerts family members when any part of the system needs attention.

  • While cardiac arrest is uncommon among children, Philips is the only manufacturer to offer specially designed pediatric pads that make automated external defibrillators safe for use on infants and children under eight or weighing less than 55 pounds. This unique feature enables the HeartStart Home Defibrillator to be used to help save anyone who suffers a sudden cardiac arrest.

    "Because sudden cardiac arrest can happen anywhere, anytime, the Red Cross continues to champion community access to defibrillation in an ongoing commitment to saving more lives," said Scott Conner, vice president, health, safety and community services, American Red Cross. "The organization's vision is that at least one person in every household be trained in lifesaving first aid, CPR, and defibrillator use, and that every American be within four minutes of a defibrillator. Since more than 70 percent of cardiac arrests happen in the home, access to a defibrillator in the home is an important step toward saving more lives."

    "Philips' relentless focus on designing the industry's easiest-to-use defibrillators reflects our resolve to help the broadest group of responders be successful in their attempt to save a life," said Deborah DiSanzo, vice president and general manager for cardiac resuscitation at Philips Medical Systems. "The HeartStart Home Defibrillator was carefully designed to help people of various ages and abilities faced with an emotionally intense emergency situation use technology successfully. We believe that the HeartStart Home Defibrillator allows Philips to extend appropriately the ability to help save a life to this newest group of responders, our family members and friends."

    The HeartStart Home Defibrillator, along with an owner's manual and instructional video, is available to consumers with a physician's prescription. Some retailers will begin offering the unit early in 2003. The manufacturer's suggested retail price is U.S. $2,295.

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