A month after regulatory approval of the Sapien XT heart valve in Japan, Edwards Lifesciences (NYSE:EW) said it won reimbursement for the transcatheter aortic valve implant from Japan’s Central Social Insurance Medical Council.
The approval follows a positive recommendation from a Japanese Ministry of Health panel that reviewed appropriate coverage policies for Edwards’ valve in patients with symptomatic aortic stenosis, according to a press release.
Reimbursement is slated to kick in Oct. 1, covering the cost of Sapien XT as well as other hospital fees, which tallies up to ¥4.53 million, or roughly $46,000 per procedure.
"We are very pleased that the Japanese government has moved swiftly to provide reimbursement for the Sapien XT valve," transcatheter heart valves vice president Larry Wood said in prepared remarks.
Sapien XT is the 1st transcatheter aortic valve implant to hit the market in Japan. It’s available in the U.S. as part of an 500-patient trial, which Edwards is ramping up after winning investigational device exemption from the FDA.