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FDA okays heart savers.

The Food and Drug Administration approved two ways of preventing heart attacks last week, and in turn had its regulations for dealing with new medical devices streamlined by the Secretary of Health and Human Services.

Aspirin and an implantable defibrillator were both okayed as heart attack preventors. The aspirin ruling permits manufacturers to inform physicians that aspirin can reduce the chance of a second heart attack occuring in a person who has already suffered one, and can lessen the chance of heart attack in people who have bouts of heart pain. The FDA based its decision on seven large studies that indicate aspirin's positive effects.

The device that received the FDA nod is a bit more dramatic. Called an implantable defibrillator (SN: 8/9/80, p. 87), it is an internalized rendition of the big metal paddles medical personnel sometimes use to shock a quivering heart into a normal pattern of beats. Developed by Michel Mirowski of Sinai Hospital and Johns Hopkins University in Baltimore, the device has proven itself in more than 700 patients.

These people had hearts that occasionally beat too rapidly (tachycardia) or quiver instead of beating (fibrillation), placing them in danger of sudden death. Each year, 400,000 to 450,000 people in the United States who go into tachycardia or fibrillation cannot be helped by drugs; mortality estimates for this group range from 27 to 66 percent in the first year. About 10,000 to 20,000 of those people are candidates for the device, estimates a spokesperson for its manufacturer, Cardiac Pacemakers, Inc., of St. Paul, Minn.

The implantable defibrillator was evaluated by the FDA because it is a medical service. Secretary of Health and Human Services Margaret M. Heckler at the same time announced streamlined regulations for drug companies submitting devices for approval. The new rules, she said, should expedite approval of other devices.
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Title Annotation:aspirin and implantable defibrillators
Author:Silberner, Joanne
Publication:Science News
Date:Oct 19, 1985
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