FDA Consumer

Lower-cost defibrillator – Updates

Lower-cost defibrillator – Updates

A new, lower-cost heart device implanted into the chest of people at risk of dying from sudden cardiac arrest has been approved by the FDA. The Cardiac Airbag implantable cardioverter defibrillator (ICD) system from Biotronik of Lake Oswego, Ore., monitors the heart’s function and automatically delivers an electrical shock when needed to restore normal heart rhythms.

The Biotronik defibrillator has fewer features than other ICDs on the market. It is priced at $10,000–about half the price of standard ICDs–and is easier to program and use than standard models. The device provides high-energy shock therapy, but does not use lower-energy pacing therapies, which are sometimes used to bring the heart back into normal rhythm. The FDA approved the Cardiac Airbag ICD in May, about two months after the firm submitted its marketing application. The agency is requiring that Biotronik conduct a two-year post-approval study of the 370 people in whom the device is implanted.

COPYRIGHT 2003 U.S. Government Printing Office

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