Edwards Lifesciences has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its Sapien 3 transcatheter heart valve for the management of severe, symptomatic aortic stenosis. The company states that it anticipates reimbursement approval from MHLW in the second quarter and plans to initiate a commercial launch in Japan immediately thereafter. Furthermore, it expects Sapien 3 to be fully launched in Japan by the end of the year.
Huimin Wang, Edwards’ corporate vice president, Japan, Asia and Pacific, says: “We are pleased to be able to offer Japanese clinicians and their patients access to the latest transcatheter aortic valve implantation (TAVI) therapy with a smaller-profile transfemoral delivery system that will allow for the treatment of many patients with small or difficult-to-navigate vasculature. We appreciate the MHLW’s progressive decision-making in allowing this device to be available to Japanese patients in a timely manner, bringing Japan alongside the US. and Europe.”
A press release claims that the Sapien 3 valve builds on Edwards’ “decades of experience” in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves. It adds that the Sapien 3 valve—approved in 20mm, 23mm, 26mm and 29mm sizes—has an outer skirt providing a seal to address paravalvular leak. The valve can be delivered via a 14Fr transfemoral eSheath introducer.