Cardiology
The First-ever Completely Self-contained Artificial Heart to Undergo Panel Review
By FDA advisory committe
Apr 21, 2005, 13:45

A June 23 meeting of FDA�s Circulatory System Devices Panel will feature cardiologists as well as cardiovascular surgeons to review Abiomed�s AbioCor artificial heart, the firm said.

The panel will consider Abiomed�s request for a humanitarian device exemption for AbioCor. In an April 20 release, the company characterized the occasion as a �special expert panel� meeting.

�This is the first-ever completely self-contained� artificial heart to undergo FDA panel review, Abiomed noted.

FDA lists June 23 as a proposed date for a panel meeting, but has not issued a formal announcement.

Abiomed submitted the HDE application in September, upon enrolling 14 of 15 required patients in a clinical trial under an investigational device exemption.

The IDE study is ongoing. Plans for a PMA will hinge on the timeline for a next-generation product, AbioCor 2, which Abiomed says could last longer, yet be 35% smaller than the first iteration. AbioCor 2 is in animal studies.

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