Edwards Lifesciences Corp. said Tuesday it is voluntarily
implementing a temporary pause on enrollment in an early study of
its experimental Fortis mitral heart valves that are implanted or
repaired via catheters instead of open-heart surgery.
The Irvine, Calif.-based maker of nonsurgical heart valves said
evidence of valve thrombosis was observed that the company thinks
warrants additional investigation. Edwards said it is working
closely with trial investigators and heart teams to gather
additional information in the study.
Edwards said that to date, the company has treated more than 20
patients globally with the experimental Fortis valve, all of whom
had symptomatic mitral regurgitation and who were either
compassionate cases or in one of its high-risk registries.
Analysts have said that nonsurgical mitral heart valves could
address an even larger market than aortic catheter valves, also
known as TAVR.
Edwards' sales of non surgical heart valves have continued to
exceed expectations lately despite increased competition. The
devices, known as transcatheter heart valves, serve as an
alternative procedure for elderly patients who are ineligible or
considered at high risk of complications in open-heart surgery.
Shares fell 1.6% to $129.60 in morning trading.
Write to Tess Stynes at tess.stynes@wsj.com
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