Edwards wins Japanese nod for next-gen Sapien valve

Edwards Lifesciences won Japanese approval for the Sapien XT valve.--Courtesy of Edwards Lifesciences

Edwards Lifesciences ($EW), locked in a heart-valve duel with Medtronic ($MDT), won Japanese approval for the Sapien XT, soon to be the first transcatheter aortic heart valve on the country's market.

Sapien XT is a sleeker, lower-profile version of the company's much-hyped implant, and Edwards said it expects to grab full reimbursement approval from Japan's Ministry of Health, Labor and Welfare by year's end and launch the device after that.

"We know that severe aortic stenosis is undertreated in Japan, and patients urgently need access to the latest therapy," Larry Wood, Edwards vice president, transcatheter valve replacement, said in a statement. "We are committed to a disciplined launch of this therapy, which includes a robust training program for Japanese heart teams."

With the approval, Edwards can add Japan to its growing list of marketing territories across Europe, Asia and Latin America, but, much to the chagrin of U.S. cardiologists, the device is not available in Edwards' home country. The company is in the midst of an FDA application for the next-gen Sapien, most recently revealing data from 560 inoperable patients with severe aortic stenosis that found the XT to be just as safe and effective as its predecessor.

Meanwhile, Edwards is fighting to maintain its market share around the globe as Medtronic notches approvals and positive study results for CoreValve, a similar device also implanted without the need for invasive chest surgery. Just how similar remains a point of contention for Edwards, as the company unsuccessfully sued its rival for patent infringement in Germany, with a court finding in favor of Medtronic this month.

Edwards is still suing over two other patents, and the company squeezed $83.6 million out of Medtronic in March when a U.S. court sided with Edwards over the same issue.

- read the announcement

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