Thoratec Gains Japanese Approval for Heart Device

Pleasanton, Calif.-based Thoratec Corporation has received approval to market its HeartMate II as a bridge-to-transplant therapy for Japanese patients with advanced heart failure.

“Approval in Japan marks a significant milestone in Thoratec’s efforts to disseminate HeartMate II to advanced heart failure patients worldwide,” said Gary F. Burbach, president and CEO. “We are enthusiastically preparing to launch HeartMate II into this important market.”

To earn approval from Japan’s Ministry of Health, Labour and Welfare, Thoratec and its distribution partner, Nipro Corporation, conducted a confirmatory clinical study, which enrolled six patients at five institutions. At more than two years of follow-up, all six patients are still alive, with three having had heart transplants and the other three supported by the device.

“We have been highly encouraged by the performance of HeartMate II in Japan, and we look forward to working closely with clinicians and Nipro to foster continued excellent clinical outcomes,” added Burbach.

Company officials expect to commercially launch HeartMate II toward the end of the first quarter of 2013, after clinician training is complete and reimbursement is in place. The initial launch will target approximately 15 hospitals, including the clinical trial centers as well as additional institutions that already are accredited to perform ventricular assist device (VAD) implant procedures. Nipro plans to have dedicated personnel in the field, trained on HeartMate II, to provide sales, marketing and clinical support for the launch. Thoratec will conduct all initial surgical training and will support Nipro with additional resources as necessary.

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a recall advisory in the United States for the HeartMate II. According to the agency, the device’s bend relief sometimes detached from its intended position. It should wrap around the proximal outflow graft; if it moves out of position, the bend relief opens the graft up to damage (including perforation), thereby reducing blood flow or causing blood clots. Also, the metal end of the bend relief is quite sharp, risking erosion of the graft. This can cause serious health problems or lead to death, the FDA contends.

Calling it a “correction” rather than a recall, company spokeswoman Susan Benton said at the time that those who have the devices implanted already will continue to use them. Thoratec has informed the FDA that it has revised the product’s labeling and clinicians have been directed to follow these revised instructions to make sure the bend relief is properly engaged.

Thoratec focuses on mechanical circulatory support; its products treat advanced heart failure.