Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor and Welfare (MHLW).
This decision follows the recent approval in Japan. The reimbursement is scheduled to go into effect on October 1, 2013.
The Sapien XT valve is reportedly the first commercially available transcatheter valve in Japan.
A reimbursement of approximately $46,000 (JPY4.53m) covers the cost of Sapien XT as well as taxes, certain hospital fees and distribution expenses per procedure.
Edwards transcatheter heart valves corporate vice president Larry L Wood noted the Japanese government has moved swiftly to provide reimbursement for the Sapien XT valve, to enable the country’s clinicians to treat patients requiring transcatheter aortic valve replacement with the latest therapy.
In the US, the Sapien XT valve is designated as an investigational device and is being studied as part of a randomized, pivotal clinical trial.