Edwards Lifesciences Launches TAVR in Japan But Financial Upside Uncertain

Edwards Lifesciences announced Monday that it has received regulatory approval in Japan for the Sapien XT which is the first transcatheter aortic valve to be cleared for sale in that country.

Reimbursement for the novel procedure, which provides a less invasive alternative for patients who are too sick to undergo open-heart surgery to replace diseased valves, is expected by the end of the year. 

But the potential for TAVR or transcatheter aortic valve replacement in Japan remains uncertain said Leerink Swann analyst Danielle Antalffy, in a research note. 

"At this point we don't carry TAVR 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...." she wrote. "Unlike many other developed markets, Japan has few hospital centers of excellence, but instead have many hospitals that attempt to be one-stop shops for local populations. This results in a decentralization of procedures and lack of specialization -- a criteria that is essential for TAVR success.

Nonetheless, she noted that overall the outlook is positive for Edwards given that elderly Japanese patients tend to favor less invasive options. Another benefit that Edwards has is a head start in the Japanese marketplace. Antalffy believes the California company has about a 12-month lead over its Minnesota rival when it comes to Medtronic introducing its TAVR product - CoreValve - in Japan. 

-- By Arundhati Parmar, Senior Editor, MD+DI