New artificial heart gains approval

NEWS IN BRIEF — Posted Sept. 25, 2006

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The Food and Drug Administration approved on Sept. 5 the sale of the first totally implanted artificial heart that involves both pumping chambers. The device had been used experimentally in just 14 patients with advanced heart failure and, although all died, they did live longer than they would have without it.

The two-pound mechanical heart, which has an internal battery, takes over the pumping function of a diseased heart and allows a recipient to be free from all external connections for up to one hour. The system includes two external batteries that allow for two hours of free movement, and it also can be plugged into an electrical outlet for longer periods of recharging or during sleep.

The heart was approved under the Humanitarian Use Device provisions of the Food, Drug and Cosmetic Act. The provisions are intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States.

Note: This item originally appeared at

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