Cardiac-Assist Devices and FDA Efforts

Originally Published MX September/October 2005

COVER STORY

Cardiac—assist devices--life-supporting products that incorporate a wide range of complex technologies—face a difficult regulatory environment. But according to D. Keith Grossman, CEO of Thoratec Corp. (Pleasanton, CA), the current clinical trials for his company's next-generation product are evidence of FDA's efforts to work with industry and clinicians in shortening the time-to-market for such products.

Thoratec's present version of its HeartMate left ventricular assist device (LVAD) is currently the only product to have FDA approval for destination therapy. Destination therapy refers to the device's use as a long-term permanent implant, designed for late-stage heart failure patients who do not qualify for transplants.

The new version of the device, HeartMate II, is currently being tested in pivotal clinical trials for both bridge-to-transplantation and destination-therapy indications. According to Thoratec, the current trials mark the first time that FDA has approved a clinical trial design that includes both indications in a single protocol.