Edwards' next-gen Sapien heart valve gains Japanese reimbursement

Japan granted an insurance reimbursement for the Sapien XT valve.--Courtesy of Edwards Lifesciences

Edwards Lifesciences' ($EW) Sapien heart-valve revenue engine gets another jolt with Japan's decision to grant insurance reimbursement for the XT model, a next-generation version.

As important as regulatory approval is for a device company's latest product, revenue growth can be slow without government health insurance coverage in place, in both the U.S. and other countries. And the move by Japan's Central Social Insurance Medical Council to grant Sapien XT reimbursement is a big deal. Japan is one of the largest healthcare markets in the world outside of the U.S., so the country's customer base is crucial.

Sapien XT won Japanese regulatory approval in June and will become the first transcatheter aortic heart valve on the market there. Designed as an updated version of the initial Sapien implant, the XT will now be covered for about $46,000 U.S. (4.53 million yen). The payment is designed to cover the cost of the device plus some amounts for taxes, hospital fees and distribution, and will kick in on Oct. 1, Edwards said.

Japan's approval of Sapien XT follows the product model's emergence in many other markets, including Europe, Asia and Latin America. It's still an investigational device in the U.S., however, part of an ongoing randomized, pivotal clinical trial. Cardiologists have complained about the pace of the U.S. approval process for this class of devices; only Edwards' first-generation Sapien has FDA approval, and rival products are a long way from entering the U.S. market.

That makes entry into the Japanese market all the sweeter for Edwards as it seeks to keep the Sapien engine running.

"We are very pleased that the Japanese government has moved swiftly to provide reimbursement for the Sapien XT valve, to enable the country's clinicians to treat transcatheter aortic valve replacement patients with the latest therapy," Larry Wood, Edwards' corporate VP for transcatheter heart valves, said in a statement.

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