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FDA Approves Wearable Cardiac Defibrillator  Dec 19, 2001

NEW YORK (Reuters Health) - The US Food and Drug Administration (FDA) said on Tuesday that it has approved the first cardiac defibrillator worn outside the body for use in patients at risk of dying from sudden cardiac arrest.

The product, made by Pittsburgh, Pennsylvania-based Lifecor Inc., is a vest-like device that is worn under clothing, rather than being implanted in the chest. The vest contains an electrode belt that touches the skin of the chest. If the device detects an abnormal life-threatening heart rhythm, and the patient loses consciousness, it delivers an electrical shock to restore normal heart function.

The FDA said that the approval was based on clinical studies in about 289 heart patients showing that the device was 71% successful in treating sudden cardiac arrest episodes, versus 25% success for patients calling 911.

Incidence of unnecessary shock was less than that seen with implantable defibrillators, which are pacemaker-like devices implanted in the chest.

``Today's approval...means a patient may now opt for a wearable defibrillator if they are not suitable candidates for an implanted defibrillator or do not want one,'' Dr. Bernard Schwetz, acting principal deputy commissioner of the FDA, said.