FDA Panel to Review Thoratec DeviceBy Associated Press November...

FDA Panel to Review Thoratec Device
By Associated Press November 28, 2007
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Government health advisers will consider Friday whether a mechanical heart pump from Thoratec Corp. should be approved, despite missing a key effectiveness goal in a company study.

Shares of the Pleasanton, Calif.-based Thoratec rose 80 cents, or 4.3 percent, Wednesday in midday trading.

The company has asked the Food and Drug Administration to approve the HeartMate II for heart-failure patients awaiting transplant. The battery-powered device is implanted in the chest, where it helps the heart's lower left chamber pump blood throughout the body. The new device is a smaller version of the company's original HeartMate model.

The FDA posted documents online Wednesday showing the Heart Mate II missed its effectiveness goal by one percentage point in a 126-patient study.

The device was considered effective if a patient survived 180 days after implantation or long enough to receive a heart transplant. The lower range of HeartMate's patient success rate was 64 percent, just under the 65 percent preset goal for effectiveness.

The FDA will ask its panel of outside cardiac experts "whether the results demonstrate a reasonable assurance of effectiveness even though the data did not meet the performance goal."

The agency is not required to follow the panel's recommendation, though it usually does.

The FDA will also question whether the device is safe and effective in smaller patients. Agency scientists noted in their review that Thoratec studied just 15 smaller-sized patients with the device, and only seven survived to meet the study's goal.

Despite concerns over effectiveness, several analysts say they expect a positive review of the device based on its safety profile.

"Safety matters more to the FDA than any other endpoint, and HeartMate II is clearly safer as well as more efficacious" than older devices, Lehman Bros. analyst Bob Hopkins wrote in a note Wednesday. Hopkins estimates the likelihood of a positive panel review at 90 percent.

Thoratec's competitors in heart devices include Oakland, Calif.-based World Heart Corp. and Australia-based Ventracor.