Medical device maker Thoratec (NSDQ:THOR) said the company won Japan’s Ministry of Health, Labor and Welfare approval for its HeartMate II, a device designed to help the heart’s pumping action in patients with severe heart disease and for use in people waiting for a heart transplant.
The Pleasanton, Calif.-based medical device maker and its distribution partner Nipro Corporation said they expected to launch the product in Japan at the end of 1st quarter next year.
"Approval in Japan marks a significant milestone in Thoratec’s efforts to disseminate HeartMate II to advanced heart failure patients worldwide," president & CEO Gary Burbach said in prepared remarks."We are enthusiastically preparing to launch HeartMate II into this important market."
Clinical trials in support of Japanese approval, which were conducted jointly by Thoratec and Nipro, showed that all 6 patients enrolled at 5 institutions survived after 2 years of follow-up. Half of those patients underwent heart transplant and the rest remain supported by the device, according to the press release.
The initial HeartMate II launch will target 15 hospitals, including the clinical trial centers and institutions that are accredited to perform ventricular assist device implant procedures, the company said.
The FDA cleared HeartMate II in January 2010 as a so-called "destination therapy," implanted indefinitely in people who aren’t eligible for a new heart.
Thoratec in March initiated a voluntary “correction” for some shipments of its HeartMate II heart pump over concerns that a portion of the outflow conduits could become detached.
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