Added use for heart device approved in six days - Food and Drug Administration approves Guidant implantable defibrillator for asymptomatic ventricular arrhythmia - Brief Article

FDA Consumer, Sept, 1996

Only six days after FDA received the application, the agency approved for wider use an implantable device that restores normal heart rhythm in heart attack patients. It is the first such approval worldwide.

The Guidant implantable defibrillator was originally approved by FDA in 1988 for patients who have had at least one cardiac arrest or have recurrent and sustained rapid heartbeat despite treatment with the best available drugs. These people are at high risk of sudden death.

FDA gave the additional approval last May 15 for a large new group of patients--about 10 percent of heart attack patients--who also are at high risk of sudden death from abnormal rapid heartbeat (ventricular arrhythmia) but who have had no obvious symptoms. These patients' arrhythmias can be detected by electrocardiograph, and usually they are treated with drugs. However, 30 percent of these patients die from ventricular arrhythmia within two years.

In a five-year clinical study, such patients implanted with the Guidant defibrillator had 54 percent fewer deaths than those treated with drugs. The significant results prompted the sponsor to stop the study early so that all patients would be eligible to receive the device.

The Guidant defibrillator is about the size of a cassette tape and is implanted in the abdomen or chest and linked to the heart with wire leads. It can be programmed to deliver small, swift pacing signals to fit patients' needs.

It is made by CPI Guidant Corp., of St. Paul, Minn.

(For more about defibrillators, see "A Gentler Jolt and Tickle for Trembling Hearts," in the April 1994 FDA Consumer.)