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Fully Implantable Artificial Heart Gets Limited FDA Approval

FDA yesterday granted Abiomed Inc. (Danvers, MA) a Humanitarian Device Exemption that will allow it to market the world's first fully implantable artificial heart, the AbioCor, according to the Boston Globe. The HDE is granted when a device can help small numbers of patients who have no alternatives.

Abiomed can't sell more than 4,000 of the devices per year and must monitor every patient who receives one. At a price tag of $250,000, the AbioCor is the most expensive and most complex medical device ever made. It aims to prolong the lives of dying patients who are too sick for a transplant. An advisory panel narrowly voted against approval last year, but the agency changed its mind after further review, deciding that patients should have the right to choose whether to receive the heart. The real litmus test, however, will come when insurers decide whether to pick up the tab. MD&DI named Abiomed one of its 50 Companies to Watch in its June 2006 issue. Abiomed will also be the subject of the Inside Look feature in the October 2006 MD&DI.

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