FDA Panel Supports Thoratec Heart Device

Government advisers recommended U.S. approval for Thoratec's next-generation heart pump Friday, despite the fact that a company study of the device fell just short of its goal.

The 10 members of the Food and Drug Administration's heart device panel voted unanimously in favor of clearing the HeartMate II for heart-failure patients awaiting transplant. The device, which helps weakened heart chambers pump blood throughout the body, is a smaller version the original HeartMate model.

The panel's endorsement came on the condition Thoratec conduct a follow-up study of the device after it reaches the market to monitor internal bleeding and other safety issues. FDA does not have to follow the advice of its panels, though it often does.

Prior to the meeting, FDA released results of a 126-patient study showing the low range of HeartMate II's success rate was 64 percent, just under the 65 percent goal needed to prove effectiveness. Success was based on whether the patient survived at least 180 days with device, or long enough to receive a heart transplant.

While Pleasanton, Calif.-based Thoratec only requested FDA approval to market HeartMate II as a temporary treatment, some analysts say its greatest market could be as a permanent therapy.

According to RBC Capital Markets analyst Ryan Bachman, the larger opportunity for the Heart Mate is among patients who are not eligible for heart transplant because they have a life expectancy under two years.

Bachman stressed in a note that permanent therapy "addresses a much larger patient population but will require a massive market development effort to drive large-scale adoption." It could take Thoratec until 2010 to win approval for the additional use, according to Bachman.

Shares of Thoratec Corp. rose 16 cents Friday to $19.75 in after hours trading, following an earlier close at $19.59 in regular trading.