Originally created 07/11/01

FDA Panel gives heart device thumbs down

WASHINGTON -- A government advisory panel voted against approving a heart pacing device on Tuesday.

The panel of outside experts concluded 6-to-2 that Contak CD, made by Guidant Corp., didn't meet the necessary effectiveness standards.

The FDA is not required to follow the recommendations of its advisory panels, but it most often does so.

The Guidant machine combines a defibrillator with an electrical device that helps regulate the beating of the heart. It's designed to assist people with failing hearts and can detect unusual rhythms and stimulate the heart with electrical pulses to restore proper beating. The company had sought approval for use of Contak CD in patients with congestive heart failure.

Somewhat similar devices are on the market, such as the pacemaker recently implanted in Vice President Dick Cheney, but his device does not have the type of heart regulator that the Guidant machine included.

Earlier this year, Guidant drew criticism from the FDA for claims it made about the device in a press release. Later, however, the FDA said an agency spokeswoman went too far in that criticism.


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