Posted from a link by Greengenes (Thanks)WASHINGTON, Nov 28...

Posted from a link by Greengenes (Thanks)


WASHINGTON, Nov 28 (Reuters) - A Thoratec Corp (THOR.O: Quote, Profile, Research) study of an experimental implanted heart pump showed it narrowly missed a preset goal to gauge effectiveness, U.S. medical device reviewers said in documents released on Wednesday.

Data gathered as of Sept. 14 showed a 64 percent success rate for the HeartMate II device, just below a pre-specified goal of 65 percent, Food and Drug Administration staff said in a summary prepared for an advisory panel review.

The FDA reviewers said they would ask the panel, which meets Friday, whether the results demonstrate a "reasonable assurance" of effectiveness. The committee is expected to vote on whether to recommend approval for the device.

The FDA usually approves products that win advisory panel backing.

The HeartMate II is a smaller version of a device the company already sells to help keep patients alive while they wait for heart transplants. The one on the market now is too large to be implanted in many women and some smaller men.

The implants, known as left ventricular assist devices, are powered by a battery-run unit outside the body. They are designed for people with severe congestive heart failure and few medical options.

Thoratec, in a separate summary, said an alternative analysis showed HeartMate II was effective. That analysis counted patients as successful cases if they had the device implanted and were eligible for transplants but were not on a waiting list.

"Effectiveness of the HeartMate II LVAS was consistent throughout all study cohorts," the company said.

Complications for patients with the Heartmate II were comparable to those seen in other studies of similar Thoratec devices, the FDA reviewers said.

Thoratec shares rose 99 cents or 5.4 percent to $19.49 in morning trading on Nasdaq.

The FDA staff and Thoratec summaries were posted on the agency Web site at
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4333b2-00-index.html.


(Reporting by Lisa Richwine, editing by Dave Zimmerman)