Edwards Lifesciences Corp. said Monday that it started to enroll patients in a Japanese clinical trial for one of its less-invasive heart valves.
The Irvine-based heart valve maker is using its Sapien XT replacement heart valve in the trial. It’s looking at patients who suffer from severe aortic stenosis, or a narrowing of the aortic heart valve.
Sapien XT, a next-generation version of Edwards’ original Sapien valve, can be implanted in a beating heart with a catheter, eliminating the need for major surgery.
Edwards said cardiovascular centers in Osaka, Tokyo and Okayama are participating in the trial; in a release, it said it anticipated that successful completion could result in Japanese approval for Sapien XT in 2013.
The company’s Sapien valves, which accounted for $39 million in first-quarter sales, and rivals are considered one of the most promising developments in replacement heart valves in recent years.
Shares of Edwards have soared in recent months, largely on investor anticipation for less-invasive heart valves. The Food and Drug Administration could approve Sapien in the U.S. in 2011.
