Thoratec, a medical device manufacturer based in Pleasanton, California, received approval from the Japanese Ministry of Health, Labour and Welfare for its HeartMate II device. The HeartMate II was approved for marketing as a Bridge-to-Transplantation therapy for advanced heart failure patients.
To ensure approval in Japan, Thoratec and Nipro Corporation, its distribution partner, conducted a clinical study of six patients. After two years of follow-up, all patients in the study are alive. Three patients in the study have received heart implants, and the remaining three patients are still kept alive by the device.
Both Thoratec and Nipro Corporation expect a commercial launch of the device in the first part of 2013. Training procedures for the system and reimbursement procedures are still being set up. The initial launch of the HeartMate II will target 15 hospitals. This includes the centers that conduct the clinical trials and facilities that have ventricular assist device (VAD) accreditation. Nipro will have personnel for clinical support, sales and marketing of the device. All initial surgical training will be conducted by Thoratec.
Gary F. Burbach is CEO and president at Thoratec. In prepared remarks, he said, "Approval in Japan marks a significant milestone in Thoratec's efforts to disseminate HeartMate II to advanced heart failure patients worldwide.” He continued, "We are enthusiastically preparing to launch HeartMate II into this important market."