FDA Panel Rules against Artificial Heart

In one of recent times' most closely watched and widely reported decisions in the medical device regulatory approval process, FDA's circulatory system devices panel ruled against granting a humanitarian device exemption (HDE) for the AbioCor artificial heart by Abiomed Inc. (Danvers, MA). Although the panel voted against recommending a “not approvable” determination, a subsequent motion asserting that the AbioCor device does not meet the requirements of an HDE passed with a vote of 7–6, with one abstention.

HDE classification is intended for medical devices that may be used in therapies for fewer than 4000 people a year, where no other treatment options exist and where the probable benefit outweighs unreasonable risk. According to FDA, 23 HDEs have been granted since 2000. Abiomed initially submitted the AbioCor for HDE consideration in September 2004.

A summary of the meeting posted on FDA's Web site notes that three motions were brought to the floor and all failed to result in a majority vote. The final outcome reflected “the difficulty the panel members had in reaching a decision on this first-of-a-kind device,” said the agency.

Abiomed chairman, president, and CEO Michael R. Minogue said, “While we are disappointed in the panel's recommendation, there is more work to be done to clarify our submission and HDE requirements. The company today is stronger than it has ever been, with 48% growth last year, 110 patents or patents pending, and $44 million in cash.”

Artificial hearts have been in development for more than 40 years, but it was not until the Jarvik 7, introduced in the 1980s by its developer, Robert Jarvik, MD, that the devices were thought to have realistic potential for clinical application. Technological progress and industry interest in such devices waned after the failure of the Jarvik heart—until the advent of the AbioCor device.