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New Product

Home Defribrillator OKED by FDA

 

EVERY 2 MINUTES, SOMEONE IN AMERICA NEEDS A DEFIBRILLATOR

Only 5% survive sudden cardiac arrest without one

The Food and Drug Administration today approved the first cardiac defibrillator designed specifically for use at home. The device, which uses a jolt of electricity to jump-start a failing heart, could let families save the lives of loved ones who collapse unexpectedly, officials said. 

aedAccording to the American Heart Association, 250,000 people die from sudden cardiac arrest (SCA) every year. In fact, more die from SCA than from breast cancer, prostate cancer, AIDS, house fires, handguns and traffic accidents combined. Each year an estimated 250,000 Americans die of cardiac arrest, when the heart stops beating without warning. Studies show that more than 70 percent of cardiac arrests occur in the home, and many victims die while waiting for paramedics.

Still, the agency's decision is contentious. Some experts fear that at-home defibrillators may actually cost lives, wasting precious minutes while distraught family members try to use the defibrillator instead of calling 911 for help.

"The overall public health impact, whether it will actually bring down the rates of death due to sudden cardiac arrest, is unknown," said, a biomedical engineer at the F.D.A., who supervised the review of the device. But, said, when defibrillators are used in the first few minutes after cardiac arrest, they are "very successful."

aedThe defibrillator approved last week, marketed by Philips Medical Systems of Andover, Mass., is a simpler, easier-to-use version of those that Philips already sells to shopping malls, office buildings and airports and other public places.

It will be available only with a doctor's prescription, however, and the F.D.A. is advising anyone who has the device to receive training in cardiopulmonary resuscitation.

"This is not an over-the-counter device," Ms. Moynahan said. "It's a prescription device that has a training requirement, and it's important that consumers work out with their physicians if they should have this device in their homes."

The agency's decision brought praise from the American Red Cross, which has promoted easy access to defibrillators. Scott Conner, a vice president, said the Red Cross envisioned all Americans being within four minutes of a defibrillator.

"With the recent F.D.A. ruling, we're one step closer to that important goal," Mr. Conner said.

The defibrillator will cost $2,295, according to Deborah DiSanzo, vice president and general manager of Philips. The company plans to begin marketing it immediately with print and Internet advertising campaigns, she said. The company also plans to promote the product among doctors.

Patients who are defibrillated within five minutes of cardiac arrest have a 50 percent chance of surviving, Ms. DiSanzo said, but for every minute that passes without help, the chance of survival drops by as much as 10 percent.

"If you get up to 10 minutes," she said, "your chance of surviving is less than 1 percent," she said.

The company intends to focus its sales effort on people 45 to 65, Ms. DiSanzo said, particularly those who have "had some brush with heart disease" or fear they will be victims of cardiac arrest.

When sudden cardiac arrest strikes, the electrical system of the heart short-circuits, causing an abnormal rhythm known as ventricular fibrillation. Shocking the heart—known as defibrillation—is the only way to effectively treat this abnormal heart rhythm. Cardiopulmonary resuscitation (CPR) can buy time for someone in cardiac arrest, but only a defibrillator can deliver a potentially life-saving shock.

Often no prior symptoms
There are risk factors for sudden cardiac arrest, including age (45 and over), smoking, poor diet, and lack of exercise, among others. But the fact is that most SCA victims have never shown any prior symptoms of heart disease. This is true for 50% of the men, and for 63% of the women who die from sudden cardiac arrest. In rare cases, sudden cardiac arrest can also result from accidents such as drowning, electrocution, choking and trauma.

The 10-minute survival window
For defibrillation to be effective, the shock must be delivered within the first few minutes of collapse. In fact, for every minute that goes by without defibrillation, a victim’s chance of survival decreases by 7-10%. And after 10 minutes, it is unlikely that the person will survive.

That’s why over the past 20 years there has been a widespread movement to place defibrillators in ambulances, fire and police vehicles, and public places such as workplaces, health clubs and sports arenas. Today, every major U.S. airline equips its planes with defibrillators.

Defibrillators at home
More than 70% of sudden cardiac arrests occur at home. When called, Emergency Medical Services arrive ready—with equipment and experience—to deliver a shock with a defibrillator. But for most people in the U.S., it takes at least 6 minutes for emergency help to arrive on the scene. Add to this the time from collapse to call, as well as any other potential delays, and it’s clear why the next logical place for defibrillators is in the home, where they can be quickly and easily accessed in an emergency.

Making defibrillators easy to use
Over the years, advances in technology and design have made defibrillators easy to operate for people like police, fire fighters and airline personnel. As defibrillators go forward into the home, they must have the same professional-grade, life-saving technology, in a streamlined design that’s easy and safe to use. Household members with minimal training need to feel confident that they can operate the defibrillator in a life-threatening, emergency situation. Plus, home defibrillators must remain ready for long periods of time and still perform if and when needed. Safety, ease of use and device readiness are paramount when taking defibrillators into the home.

The HeartStart Home Defibrillator by Philips
Now that you know the basics of sudden cardiac arrest, the role early defibrillation plays in its treatment, and the importance of a defibrillator for the home, where over 70% of sudden cardiac arrests occur, it’s time to highlight the HeartStart Home Defibrillator.

 


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