The company anticipates reimbursement approval from MHLW in the second quarter and plans to initiate a commercial launch in Japan immediately thereafter. The company expects to be fully launched in Japan by the end of the year.
"We are pleased to be able to offer Japanese clinicians and their patients access to the latest TAVR therapy with a smaller-profile transfemoral delivery system that will allow for the treatment of many patients with small or difficult-to-navigate vasculature," said Huimin Wang, M.D., Edwards’ corporate vice president, Japan, Asia and Pacific.
"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 U.S. and Europe."
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.
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 14-French transfemoral eSheath introducer.
The SAPIEN 3 valve received commercial approval in Europe in January 2014 and in the U.S. in June 2015. In Japan, the SAPIEN XT valve was the first transcatheter heart valve introduced by Edwards in October 2013.
The SAPIEN family of valves has been used in the treatment of more than 140,000 patients globally.
