Edwards Lifesciences Corporation, is trumpeting the news that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country’s first commercially available transcatheter aortic heart valve.
The company expects to obtain reimbursement approval from MHLW by year’s end, and will initiate a full launch in Japan immediately thereafter.
Visitors to our pages will be very familiar with the developing transcatheter aortic valve story, which is one of clinical and regulatory milestones. Each time one of the main protagonists advances another rung on the ladder we’re very likely to hear about it, especially when the news relates to Japan with its notoriously rigorous regulatory regime.
While Sapien XT remains commercially unavailable in the United States, it has been widely adopted by implanting physicians in Europe since its launch in 2010.
The Japanese approval comes on the back of a clinical study undertaken in the country, conducted in leading cardiovascular centers Osaka University Hospital (Osaka), Sakakibara Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama).
“We know that severe aortic stenosis is undertreated in Japan, and patients urgently need access to the latest therapy. We are pleased that Japanese regulators took a progressive approach to the approval of SAPIEN XT, focusing their review process on the valve that is the market leader in Europe, rather than our previous generation transcatheter valve,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter valve replacement. “We are committed to a disciplined launch of this therapy, which includes a robust training program for Japanese heart teams.”
Source: Edwards Lifesciences Corporation