Edwards Lifesciences has reported that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare (MHLW)'s expert review panel to provide reimbursement for Edward's Sapien XT transcatheter aortic heart valve. The reimbursement is scheduled to go into effect on October 1.
This decision follows regulatory approval of the Sapien XT valve in June. With this approval, Chuikyo established a reimbursement of JPY 4.53mn (approximately US$46,000) for when the Sapien XT valve is used in the treatment of patients with severe symptomatic aortic stenosis. The Sapien XT valve is the first commercially available transcatheter valve in Japan. In the US, the valve is not commercially available; it is an investigational device being studied as part of a randomised, pivotal clinical trial.