PHILIPS

Philips Announces Its HeartStart Defibrillators Will Meet New American Heart Association 2005 CPR and ECC Guidelines

Andover, Massachusetts, USA - Royal Philips Electronics (NYSE: PHG; AEX: PHI), a worldwide leader in defibrillation technology, today announced that its entire line of HeartStart Defibrillators will meet the newly updated American Heart Association Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC). The European Resuscitation Council (ERC) has also released its Guidelines for Resuscitation 2005 and Philips will meet those as well.

Defibrillators treat the most common cause of sudden cardiac arrest (SCA), an electrical malfunction of the heart that causes it to beat erratically rather than pump in a normal rhythm. SCA is one of the leading causes of death in the United States, claiming more than 340,000 lives each year or nearly 1,000 people each day. Approximately 95 percent of these deaths occur before victims can get to a hospital or emergency room.

Philips HeartStart defibrillators were developed with the insight that the science behind resuscitation is constantly evolving. Virtually all HeartStart defibrillators currently available, including the Home, OnSite, FRx, FR2+, ForeRunner, and MRx, can be reconfigured now to support the new one-shock defibrillation protocol recommended in the 2005 Guidelines. Clinical studies have shown that the technology in HeartStart Defibrillators has a greater than 95 percent first-shock efficacy. For devices with CPR coaching and feedback capabilities, a software update will be available in 2006 to address the Guidelines' new CPR protocols.

In the meantime, the AHA states that these new recommendations do not mean the use of previous guidelines is either unsafe or ineffective, including the use of defibrillators that were designed to conform to those earlier guidelines. Philips HeartStart Defibrillators provide medical directors with the flexibility to change their defibrillation and CPR protocols on their own schedule, as they consider how best to implement the 2005 Guidelines to meet the needs of their particular program.

Since the AHA last updated the Guidelines in 2000, numerous research studies have shown that effective CPR is a critically important element in helping save the lives of cardiac arrest victims. These studies were emphasized in the development of the new guidelines. Responding to the same science, Philips recently introduced a range of resuscitation technology solutions designed to ensure that quality CPR and early defibrillation are delivered quickly and effectively. Philips commitment to continually help improve survival from sudden cardiac arrest is evidenced through the introduction of innovative technologies such as:

  1. Q-CPR TM: the first and only technology integrated into a monitor/defibrillator to provide real-time CPR monitoring and feedback for advanced life support (ALS)-trained responders. Two studies presented at the recent American Heart Association Scientific Sessions, found that incorporating Q-CPR into the rescue protocol of both hospital and emergency medical services professionals helped them improve the quality of CPR they deliver. The new Guidelines give CPR prompting devices a Class IIb recommendation for both in- and out-of-hospital settings. Q-CPR, developed by Philips and Laerdal Medical, is a feature available only on the Philips HeartStart MRx Monitor/Defibrillator.
  2. SMART CPR: first-of-its-kind technology that automatically advises a responder whether to provide an immediate defibrillation shock, or CPR followed by a shock, when treating a patient in ventricular fibrillation (VF), the most common heart rhythm associated with cardiac arrest. SMART CPR helps the responder make better-informed treatment decisions. SMART CPR is a feature available only on the Philips HeartStart FR2+ Automated External Defibrillator (AED).
  3. Quick Shock: technology which enables a defibrillation shock to be delivered quickly after CPR is stopped - up to three times faster than other solutions on the market. Quick Shock is only available in the HeartStart MRx, FR2+, FRx, OnSite and Home Defibrillators.
  4. CPR Coaching: a coaching tool for both adult and infant/child CPR, provides audio cues for each breath as well as the appropriate number, depth, and rate of chest compressions. This technology is available on the HeartStart FRx, OnSite, and Home Defibrillators.

For more information about the 2005 guidelines, please visit the AHA website at: http://www.americanheart.org

For more information about Philips HeartStart Defibrillators, please visit the Philips website at: www.philips.com/heartstart

 

ZOLL AED Plus

Guidelines 2005 Guarantee

ZOLL Medical Corporation hereby commits to all purchasers of an AED Plus defibrillator after October 3, 2005 that in the next year ZOLL will make available to any requesting purchaser a set of simple tools that will change the operation of the AED Plus as required to meet the cardiopulmonary resuscitation protocol in Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, International Consensus on Science, to be published by the American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR).

ZOLL further guarantees that the tools to perform this upgrade will be provided to such purchasers of an AED Plus at no cost. Any monetary costs for transmitting or shipping these tools for upgrade will be borne in total by ZOLL.

ZOLL expects that these tools will perform an upgrade to the software of the AED Plus so as to meet the new Guidelines. ZOLL agrees to provide, in Compact Disc format, all software needed to perform this upgrade, along with updated versions of supporting documentation. ZOLL will also provide labeling if needed. ZOLL will also provide complete and clear instructional materials for performing this upgrade.

This upgrade will require the purchaser of the AED Plus to utilize a personal computer with infra-red modem and CD-ROM drive in order to perform the software upgrade of the AED Plus. The purchaser may also be required, as part of the upgrade process, to download software or software upgrades from the zoll.com web site.

* ILCOR members include the American Heart Association, the Australian Resuscitation Council, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, the Inter-American Heart Foundation, the New Zealand Resuscitation Council, and the Resuscitation Council of Southern Africa. © 2005 ZOLL Medical Corporation. All rights reserved.



American Heart Association Updates

DATE: 30 August 2005

The American Heart Association collaborates with the International Liaison Committee on Resuscitation (ILCOR) to evaluate peer-reviewed, published scientific evidence related to emergency cardiovascular care (ECC) in an ongoing scientific consensus process. Every five years, the ECC Committee of the American Heart Association publishes revised ECC Guidelines, in accordance with the outcome of the ILCOR consensus on science and within the context of medical practice and education in the United States. Changes to treatment recommendations are, on occasion, made through scientific statements that may be published more frequently than the full ECC Guidelines.

The recommendations in the 2005 AHA Guidelines for ECC and CPR (to be published in December 2005) will confirm the safety and effectiveness of many existing approaches, acknowledge that some may not be optimal, and introduce new treatments that have undergone intensive evaluation. These new recommendations do not imply that care involving the use of earlier guidelines is either unsafe or ineffective, including the use of AEDs that are designed to conform to those earlier guidelines. For this reason the AHA encourages implementation of (and training for) life-saving medical emergency response plans (including AED programs) to continue without interruption or consideration of the pending publication of the 2005 AHA Guidelines and the associated training materials.

Once the new guidelines are published, the American Heart Association will begin releasing revised training materials to support each of its ECC curricula. The release of those materials will not occur immediately after the guidelines nor will they occur simultaneously (Basic Life Support materials will precede Advanced Cardiovascular Life Support materials). An interim training bulletin will, however, be released in January 2006 that will provide guidance for the application of the new guidelines, especially as they relate to the use of existing AEDs.

Sincerely,

Jerry Potts, PhD ECC

Director of Science


The Latest Home Appliance

Many people buy smoke detectors, fire extinguishers and security systems for their homes. Now the question is: Should a heart defibrillator be included in a home safety kit?
The issue is being hotly debated in the medical community since the Food and Drug Administration last month approved the sale of automated external defibrillators without a prescription. The portable device shocks the heart back into the proper beat after a sudden cardiac arrest. But an AED is expensive, costing $2,000, and typically isn't covered by insurance. Although the FDA decision allowed AEDs to be sold without a prescription, there's little guidance on who should get one. Right now, people with known risk factors for heart attack, people over 50 and those living in rural areas are likely the best candidates. But whether the expense is worth it -- or whether users will be calm enough to shock their loved ones -- simply isn't known. Some doctors think more study is needed before recommending AEDs for home use. But proponents say AEDs should be viewed like smoke detectors, seat belts and air bags: The majority of people won't need them but the devices are lifesavers if they do. The numbers appear to favor that argument.

It's estimated that as many as 450,000 people die of sudden cardiac arrest each year.

By comparison, about 41,000 people die in car accidents each year. Home fires claimed the lives of 2,670 people. A cardiac arrest occurs when the lower chambers of the heart start beating rapidly. It is sudden and unpredictable, and renders the patient unconscious. To recover, the heart must be shocked into a normal rhythm with a defibrillator. For every minute past the arrest that the victim isn't shocked, the chance of survival drops by about 10%. The national survival rate of a sudden cardiac arrest is only 5%. We already know that AEDs in public places like airports and casinos have had a huge impact, boosting survival rates to 80% or better. While it's easy to argue the value of a defibrillator in a high-traffic area, it isn't yet clear whether AEDs in the home are worth the cost. Studies are under way to gauge the benefit, but results won't be known for about three years.

It's estimated that 80% of sudden cardiac arrests occur at home.

The more difficult question is who should buy one because sudden cardiac arrest, by definition, is unpredictable most of the time. Of those who die from cardiac arrest, 50% of men and 64% of women don't have symptoms of heart disease. Patients known to be at high risk for cardiac arrest probably don't need a home AED because they should be talking to their doctors about implantable devices that automatically shock the heart when they detect a rhythm change. Some experts think anyone over 50 who can afford it should buy a home AED. But the fact remains that most people who have an AED probably won't ever use it.
That's not how Lee Curtes of Erin, Wis., sees it. Mr. Curtes purchased an AED for his home after a ski-patrol team used a portable AED to save his life on the top of a ski slope four years ago. He takes the machine with him in the car and on vacation. "I'm 59 years old and all my friends are around that age," says Mr. Curtes, a retired heating- and air-conditioning business owner. "I don't know that I bought it for myself as much as I bought it to save a life the way mine was saved."
People who live in rural communities where emergency-response times are slow should think about a home AED. One idea may be for neighborhood groups to purchase a few devices and notify residents how to get them and use them in an emergency. An AED might be useful in a church or synagogue, and some parents have purchased AEDs for schools. The devices are surprisingly simple to use -- even by children. The Philips HeartStart AED approved for over-the-counter sale is about the size of a hardcover book. Pull a handle to activate the machine and a calm voice offers step-by-step instructions, from removing a patient's clothes to how to place two adhesive pads. The voice tells you when to press an orange button to deliver a shock. The voice will speak quickly or slow down depending on how quickly the user finishes a task. The $2,000 Philips device can be purchased directly from the manufacturer at www.heartstarthome.com, but some Web retailers offer it for as low as $1,600. Other AED models retail for as low as $1,000 but still require a doctor's prescription. Some AED models are also sold at major pharmacies like Walgreens or medical-supply stores. While AEDs may be easy to use, one thing to ask before buying a device: Will you have the composure to use one in an emergency? Some experts have questioned whether a distraught family member would have the wherewithal to use a defibrillator during a crisis or whether the device might make people forget to call 911. "Will it be used or will people be in too much shock?" asks Stephen Siegel, cardiologist at NYU Medical Center and clinical assistant professor at the New York University School of Medicine. "I don't know how easy I could use a defibrillator on my wife or mother." University of Washington professor Gust Bardy, who is leading a study of home defibrillators and a consultant for AED makers, says that during the past few decades, he has encountered six cardiac arrests outside the hospital. The only person who survived was a woman who collapsed in the Denver airport, near a defibrillator that he used to resuscitate her. Dr. Bardy personally owns three of the devices -- one for his home and one in each of his cars. "The healthy way to look at it is that you're just throwing away $2,000," says Dr. Bardy. "That would be the ideal use of the device."