FDA Approves Devices For Restarting Heart
Sep. 12, 1996
WASHINGTON (AP) _ The Food and Drug Administration has approved the nation's smallest, lightest and cheapest device to restart stopped hearts, a move cardiologists hope will make defibrillators as common as fire extinguishers.
Over 300,000 Americans die every year from sudden cardiac arrest. Many might have been saved if health workers could have delivered an electrical shock to restart the heart in the first critical minutes.
Defibrillators can do just that, and every paramedic unit in the nation carries one. But paramedics aren't usually the first to respond to an emergency, and cardiologists are demanding smaller, more affordable devices that could become standard equipment for police officers, firefighters, even airplane flight attendants.
Late Wednesday, the FDA approved the first in a new wave of these units, Heartstream Inc.'s ForeRunner.
About the size of a book, it weighs just 4 pounds, half the weight of the smallest unit now available. It will cost between $3,000 and $4,000, compared with the $5,000 to $7,500 price tags common for today's defibrillators.
``This unit will have a lot of merit,'' said Dr. Roger White of the Mayo Clinic, who spearheaded a campaign to put defibrillators in police cars in Rochester, Minn. The city now has the nation's highest survival rate for sudden cardiac arrest.
Today, fewer than 25 percent of all emergency response vehicles and less than 1 percent of police cars carry defibrillators. Critics say that's one reason the survival rate for sudden cardiac arrest averages 5 percent and just 1 percent in New York City, the nation's worst rate as emergency workers battle traffic and slow elevators to reach victims.
In Rochester, Minn., half the patients reached by emergency workers within five minutes of cardiac arrest survived, said Heartstream President Alan Levy.
``If patients get defibrillated earlier, they can have high survival rates _ and it's the only thing that works,'' he said.
The FDA cleared the ForeRunner based on studies of 300 patients that found it worked as well as older, larger defibrillators. However, the agency did restrict one use that Heartstream had hoped for. It cannot be used on airplanes because no one knows if altitude could affect its performance.