Panel urges FDA to back new Thoratec heart pump

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) - Thoratec Corp's newest implanted heart pump should be approved for keeping patients alive while they wait for heart transplants, a advisory panel unanimously said on Friday.

The Food and Drug Administration will now decide whether to clear the device, called HeartMate II. The FDA usually follows panel recommendations.

The committee supported the product even though a Thoratec study narrowly missed a pre-specified goal for proving the implant was effective enough. FDA reviewers had asked the panel's input on whether those findings were sufficient.

"I think the sentiment here is that we have met a reasonable assurance of effectiveness," said Dr. Warren Laskey, the panel chairman and a University of New Mexico cardiologist.

The panel, a group of experts from outside the FDA, urged the agency to require a post-approval study to gather more information about bleeding episodes and others issues.

The HeartMate II and similar implants, known as left ventricular assist devices, are designed for people with severe congestive heart failure and few medical options.

Older versions are too bulky for many women and some smaller men. The HeartMate II is smaller than Thoratec's other models, about the size of a D battery, making it a possible option for a wider range of patients.

A company-funded study of 126 patients showed a 64 percent success rate for the HeartMate II device, just below a pre-specified goal of 65 percent, FDA reviewers said.