October 8, 2004, Nursezone.com Are In-Home Defibrillators Changing Emergency Response?
October 5, 2004, The News Journal Defibrillator available over the counter
September 22, 2004, NPR: Day to Day Jump-Starting Hearts at Home
September 21, 2004, AAMI News Over-the-Counter Defibrillator Gets FDA Nod
September 2004, Merginet FDA Clears Over-the-Counter Sale of AEDs
September 20, 2004, Boca Raton News In home lifesaver Emergency responders praise decision allowing citizens to purchase home defibrillators without prescriptions
September 21, 2004, USA Today Built-in features help avoid mistakes in a crisis
September 17, 2004, Mass High Tech Philips gets FDA OK to sell defibrillator over the counter
September 17, 2004, Consumer Affairs FDA Clears In-Home Defibrillators
September 17, 2004, Senior Journal FDA Clears First Over-the-Counter Sale of Automatic External Defibrillator
September 17, 2004, Boston Herald Defibrillator is readied for holiday retailing: Mom's plea inspired, FDA made it possible
September 16, 2004, Associated Press Home defibrillator without prescription OK'd FDA approves device for use in cases of sudden cardiac arrest
September 15, 2004, Family Practice News FDA panel weighs OTC availability of home defibrillator: untrained users were able to set up the device promptly and safely deliver shocks.
September 1, 2004, Pediatric News FDA panel positive on OTC status for defibrillator: questions remain on pediatric indication
August 19, 2004, The Detroit News Home defibrillator debate grows- FDA may allow sale without prescription; doctors question use by family members
August 11, 2004, The Economic Times Shock therapy for failing hearts
August 6, 2004, WebMD A Lifesaving Machine Over the Counter? FDA Panel OKs No-Prescription Sales of Home Defibrillator
August 1, 2004, Eagle-Tribune Home Defibrillator Could Shock Sales at Philips
July 28, 2004, Business Wire FDA Panel Considers Over-The-Counter Home Defibrillator
July 26, 2004, San Francisco Chronicle Taking Doctors' Orders Out of Defibrillators
Press Information September 16, 2004 FDA Clears the Philips HeartStart Home Defibrillator for Over-the-Counter Sale Andover, Massachusetts ? 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 [email protected] Steve Kelly, Philips Medical Systems Tel: +1 425 487 7479 [email protected] Jayme Maniatis or Dana Conti for Philips Medical Systems Tel: +1 781 684 0770 [email protected] 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) About Royal Philips Electronics Royal Philips Electronics of the Netherlands (NYSE: PHG, AEX: PHI) is one of the world's biggest electronics companies and Europe's largest, with sales of $32.8 billion (EUR 29 billion) in 2003. With activities in the three interlocking domains of healthcare, lifestyle and technology and 165,600 employees in more than 60 countries, it has market leadership positions in medical diagnostic imaging and patient monitoring, color television sets, electric shavers, lighting and silicon system solutions. News from Philips is located at www.philips.com/newscenter. Philips HeartStart Defibrillator News.