Japan clears HeartMate II as bridge therapy

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Japan’s Ministry of Health, Labor and Welfare has approved HeartMate II as a bridge-to-transplantation therapy for patients suffering from advanced heart failure.

Approval was based on a study conducted by Thoratec and its distribution partner, Nipro, according to Thoratec. The study enrolled six patients at five institutions. At two years of follow-up, all patients were alive, with three having been transplanted and the other three still supported by the device.

Thoratec and Nipro anticipate a commercial launch of HeartMate II toward the end of the first quarter of 2013, after centers have been trained and reimbursement is in place. The initial launch will target approximately 15 hospitals, including the clinical trial centers as well as additional institutions that are accredited to perform ventricular assist device implant procedures.

Thoratec in based in Pleasanton, Calif., and Nipro is headquartered in Osaka, Japan.