Ed Kensik05.17.06
Pleasanton, CA-based Thoratec announced that the FDA gave its approval to add 90 more patients to a study of a new implant to regulate blood flow in heart patients.
Originally, the mid-stage clinical trial for the HeartMate II called for 133 patients, of which 115 are now enrolled. Once that enrollment is complete, up to 90 more participants can be signed up for the study, which will test the effectiveness of the device.
The device uses a rotary pump that regulates blood flow for long-term support of advanced-stage heart failure patients, who are ineligible for heart transplants.
Thoratec already has two heart implant devices on the market and develops and markets diagnostic test systems.