Edwards Lifesciences (NYSE:EW) won the green light from Japanese regulators for its Sapien XT transcatheter aortic heart valve system, the 1st device of its kind to hit the shelves in the island-nation.
The Irvine, Calif.-based company’s Sapien XT valve is a next-generation version of its original Sapien TAVI system, with material changes to the stent frame, the valve leaflet and the catheter to make the device thinner and smaller than its predecessor.
According to a company statement, the Japanese Ministry of Health, Labor and Welfare will approve reimbursement for Sapien XT by the end of the year, at which time Edwards will begin a full commercial launch.
Leerink Swann analyst Danielle Antalffy affirmed in a note to investors this afternoon that the Japanese regulatory win was in line with estimates.
"At this point we don’t carry [transcatheter heart valve replacement ] sales for Japan in our model as there are many structural issues still outstanding surrounding who and how many physicians will be eligible to perform the procedure, but we maintain a favorable outlook as the Japanese have typically been adverse to invasive surgical procedures – a positive for TAVR," Antalffy wrote.
"Based on trial initiation time-lines we believe [Edward Lifesciences] could have a 1+ year head start in Japan vs. MDT’s [MP] CoreValve – enough to give it a slight edge in this nascent TAVR market," she added. "We remain Outperform rated as we continue to assess the viability of this long-term market opportunity and reiterate our $85 12-month valuation."
The news didn’t lead to much movement on Wall Street, with EW stocks up just 0.3% as of about 3:15 p.m. EST today.
In addition, The FDA’s month-long inspection of its Draper, Utah, manufacturing facility still hasn’t stirred much concern on Wall Street, despite the recalls and a preemptive company note to investors.