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U.S. FDA Approves In-Home Cardiac Defibrillator (dateline April 2, 2003)

The U.S. Food and Drug Administration (FDA) recently announced that it has approved a cardiac defibrillator for use in the home. According to Philips Medical Systems, the company that market’s the HeartStart Home defibrillator, more than 70% of sudden cardiac arrests occur in the home, and fewer than 5% survive. A shock from the defibrillator within the first few minutes after cardiac arrest can help saves lives, though some experts worry that family members will focus more on using the defibrillator than calling 911 for emergency help.

Coronary artery disease is the leading cause of death in the United States and many other countries. Approximately 12.8 million American suffer from coronary artery disease. A heart attack occurs when a blocked coronary artery causes a portion of the heart muscle to die. Cardiac arrest may also result from coronary artery disease; 90% of sudden deaths occur in people with two or more major arteries blocked by plaque build up.

Cardiac defibrillators work by providing a quick electrical shock to the heart to reestablish normal contraction rhythms in patients whose heart is not beating properly (e.g., in those who have experienced cardiac arrest). Small, portable defibrillators are called automated external defibrillators (AEDs). An AED marketed by Philips Medical Systems is already available in many shopping malls, airports, and other public places, and the newly approved in-home defibrillator is essentially the same model with some design modifications to help make it fast and easy to use.

The in-home defibrillator will cost $2,295 and will be available only by a doctor’s prescription. Philips Medical Systems plans to begin marketing the defibrillator immediately.

The American Red Cross supports access to cardiac defibrillation to help save lives. However, the organization also recommends that anyone who plans to have an in-home cardiac defibrillator also become trained in cardiopulmonary resuscitation (CPR). "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," said Scott Conner, Vice President of Health, Safety and Community Services at the American Red Cross, in a Philips Medical Systems news release. First aid and CPR training are available to the public through the Red Cross and other organizations across the United States.

In addition, everyone should also be familiar with the common warning signs of a heart attack:

  • Uncomfortable pressure, fullness, squeezing or pain in the center of the chest lasting more than a few minutes
  • Pain spreading to the shoulders, neck or arms
  • Chest discomfort with lightheadedness, fainting, sweating, nausea or shortness of breath

If an adult experiences cardiac arrest in the home, family members should call 911 immediately, before beginning CPR or using a defibrillator.

Other major makers of cardiac defibrillators (AEDs) include Medtronic, Agilent Technologies, Siemens Medical Systems, General Electric, and Survivalink.

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