Japan's regulators approve Thoratec's HeartMate II pump
Thoratec's push to keep sales surging for its HeartMate II pump will move to Japan, now that regulators have signed off on the device. Plans call for a commercial launch to begin at the end of the 2013 first quarter.
The California device company ($THOR) gained approval there to market HeartMate II as a bridge-to-transplant therapy for patients who have advanced heart failure. Japan is a significant market for medical devices--one of the largest in the world--so the approval represents a major victory for the company.
Not surprisingly, then, president and CEO Gary Burbach said in a statement that the company is "enthusiastically preparing to launch HeartMate II into this important market."
Thoratec will roll out the device working with distribution partner Nipro, with an initial target of 15 hospitals (the respective locations will have training and must also deal with reimbursement issues first). Other centers already accredited to handle ventricular assist device implants will be included in the marketing push. Thoratec plans to conduct surgical training, but Nipro will handle sales, marketing and clinical support.
HeartMate has been a valuable asset for Thoratec, with revenue generated by the line hitting close to $324 million in the first 9 months of 2012, a 19% jump over the previous year. The device faced an FDA class I recall earlier in 2012, but that hasn't really affected HeartMate's earnings. Pivotal trials, meanwhile, are planned for Thoratec's HeartMate II and HeartMate PHP ventricular assist devices in 2013. The company itself remains an acquisition target with observers in the post-U.S. health care reform environment viewing the cardiac industry as ripe for consolidation.
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