By FDA advisory committe, [RxPG] A June 23 meeting of FDAs Circulatory System Devices Panel will feature cardiologists as well as cardiovascular surgeons to review Abiomeds AbioCor artificial heart, the firm said.
The panel will consider Abiomeds 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.
