The FDA has cleared Thoratec Corp.'s HeartMate II, a heart-pump device designed for heart-failure patients awaiting transplants. The product, which is a smaller version of the firm's HeartMate XVE device, can be implanted in patients of smaller body size. "Until now, some heart-transplant candidates have been underserved due to the large size of previously approved heart-assist devices," said the director of the FDA's Center for Devices and Radiological Health.

Related Summaries