|
|
The First-ever Completely Self-contained Artificial Heart to Undergo Panel Review
Apr 21, 2005, 13:45, Reviewed by: Dr.
|
|
�This is the first-ever completely self-contained� artificial heart to undergo FDA panel review.
|
By FDA advisory committe ,
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. 
- FDA�s Circulatory System Devices Panel
www.fdaadvisorycommitte.com
This meeting will be held June 23, 2005 at [to be announced].
|
For any corrections of factual information, to contact the editors or to send
any medical news or health news press releases, use
feedback form
Top of Page
|
|
|
|
