Edwards Lifesciences Corp on Tuesday said it stopped enrolling patients in a small study of its less-invasive mitral heart valve device due to the formation of blood clots associated with the procedure.
The company, which introduced a catheter-based approach to replacing diseased aortic heart valves in the U.S. market in 2011, is working to adapt the technique for the mitral valve.
The experimental mitral valve, Fortis, had been implanted in more than 20 patients before it halted the study, Edwards said.
The so-called transcatheter approach to heart valve replacement, in which the valve is threaded through the arteries to the heart, spares the patient from traditional open-heart surgery.
Edwards said it voluntarily implemented a temporary pause in the program to assess valve thrombosis, or clotting, observed in patients. The company said it remains committed to transcatheter mitral valve replacement.
"While the program freeze is certainly disappointing, it doesn’t necessarily change its competitive positioning much in a market where everyone is still in the very early stages of development," J.P. Morgan analyst Michael Weinstein said in a note to clients.
The medical device maker's shares fell as much as 4.7
percent before recovering to trade at $129.61, down 1.6 percent, at midday on the New York Stock Exchange.
