The Japan's Ministry of Health, Labour and Welfare has approved Thoratec's HeartMate II for use as a Bridge-to-Transplantation therapy for patients with advanced heart failure.
The approval was based on a confirmatory clinical study, which enrolled six patients at five institutions.
The study, conducted by Thoratec and its distribution partner Nipro, demonstrated that at over two years of follow-up, all six patients are alive, with three having been transplanted and the other three still supported by the device.
Thoratec president and chief executive officer Gary Burbach said, "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."
Thoratec and Nipro are planning to launch HeartMate II at the end of the first quarter of 2013, after clinical trial centers have been trained and reimbursement is in place.
The initial launch will take place at 15 hospitals including the clinical trial centers as well as additional institutions which are accredited to perform ventricular assist device implant procedures.