Japan Approves Reimbursement for Edwards' Sapien XT Valve

August 21, 2013—Edwards Lifesciences (Irvine, CA) announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards Sapien XT transcatheter aortic heart valve. The reimbursement is scheduled to go into effect on October 1.

The company announced regulatory approval of the Sapien XT valve in Japan on June 24, 2013.

According to Edwards Lifesciences, the Japanese Chuikyo approval establishes a reimbursement of 4.53 million yen (approximately $46,000 at current exchange rates) for when the Sapien XT valve is used in the treatment of patients with severe symptomatic aortic stenosis. The reimbursement rate for medical devices in Japan covers the cost of the device as well as taxes, certain hospital fees, and distribution expenses.

In the United States, the Sapien XT valve is an investigational device being studied as part of a randomized, pivotal clinical trial; it is not commercially available, advised the company.