Press Release
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19 October, 2005
Philips announces FDA clearance for the HeartStart FR2+ with SMART CPR, the first automated external defibrillator (AED) to advise responders whether to initially treat cardiac arrest with a defibrillation shock or with CPR followed by a shockThe FR2+ with SMART CPR helps first responders make better informed treatment decisions Andover, Massachusetts, USA - Royal Philips Electronics (NYSE: PHG; AEX: PHI), today announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing its HeartStart FR2+ with SMART CPR, the first Automated External Defibrillator (AED) that advises the user whether to provide an immediate defibrillation shock, or CPR followed by a shock, to a victim of sudden cardiac arrest (SCA).
Defibrillation is recognized as the definitive treatment for ventricular fibrillation (VF), the abnormal heart rhythm most often associated with SCA. However, published studies have found that patients with a heart rhythm typical of long-duration VF responded better to a defibrillation shock if they received CPR first.
Until now, AEDs have generally treated all VF patients the same, by providing an initial defibrillation shock. SMART CPR takes treatment to the next level. When a medical director enables and configures SMART CPR, the FR2+ can help users make more refined treatment decisions for each patient. Once a heart rhythm is determined to warrant a shock, the FR2+ further analyzes key characteristics of the patient’s heart rhythm and suggests an initial treatment – either a shock or CPR followed by a shock. The FR2+ automatically adjusts its protocol and voice prompts accordingly.
“Since every patient and circumstance is different, and responders do not always have complete information, it is extremely important to have technology that is capable of helping the responder make the most informed decisions in treating victims of sudden cardiac arrest,” said Dr. Bill Fales, associate professor of Emergency Medicine at Michigan State University College of Human Medicine and medical director of the Kalamazoo County (MI) Emergency Medical Services System. “We are looking forward to seeing how the FR2+ with SMART CPR will impact the treatment of sudden cardiac arrest patients by first responders, and how it may improve patient outcomes.”
“Clinical research has shown that CPR is sometimes the best initial therapy for victims of sudden cardiac arrest. The introduction of the FR2+ with SMART CPR is an important step in applying the results of this research to help more patients,” said Deborah DiSanzo, senior vice president and general manager, cardiac systems, for Philips Medical Systems. “Philips is pleased to expand its portfolio of industry-leading CPR and defibrillation solutions for all types of responders with the introduction of this innovative technology.”
SMART CPR will be available on the HeartStart FR2+ later this year. About CPR and Defibrillation CPR, or cardiopulmonary resuscitation, is a technique intended to temporarily circulate oxygenated blood though the body of a person whose heart has stopped or has an erratic rhythm unable to sustain circulation. CPR can also “prime” the heart to receive a defibrillation shock by perfusing it with oxygenated blood.
SCA affects 340,000 people each year in the US alone, and fewer than 5% survive, largely because defibrillators do not get to them in time. For each minute that passes before delivering defibrillation therapy, the chance of survival decreases about 7-10%. However, studies suggest that there is an opportunity to improve survival rates and save more lives by employing a response protocol delivering CPR in advance of a shock in certain cases. The FR2+ with SMART CPR is the only AED that supports such a protocol.
Royal Philips Electronics of the Netherlands (NYSE: PHG, AEX: PHI) is a global leader in healthcare, lighting and consumer lifestyle, delivering people-centric, innovative products, services and solutions through the brand promise of “sense and simplicity.” Headquartered in the |
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