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| Edwards' Fortis mitral transcatheter heart valve--Courtesy of Edwards |
Mitral valve replacement is intended to be the next big thing at Edwards Lifesciences ($EW), though it's still in the early research stage. But, for now, the company has paused a clinical trial due to safety concerns. Specifically, the company said it has "observed evidence of valve thrombosis" in a clinical trial of its Fortis transcatheter mitral valve replacement device.
It has opted to voluntarily pause enrollment in the study to further investigate the safety issue. So far, more than 20 mitral valve disease patients have been treated with the Fortis valve. All of them had severe disease and had risk factors preventing them from undergoing surgery.The patients were all either compassionate cases or from Edwards' high-risk registries.
The Fortis valve incorporates bovine pericardial tissue and has a cloth-covered, self-expanding frame that's intended to minimize paravalvular leak, as well as a unique anatomical anchoring system. The implant is performed via a transapical approach, so it goes into the body via a small incision in the chest directly under the heart.
Edwards said it remains committed to transcatheter mitral valve replacement, but didn't offer a timeline for when the trial might resume. The company had planned to make major decisions around Fortis involving the pursuit of a CE mark and additional, potential design enhancements before the end of the year. Fortis hasn't been approved for sale in any country.
"We'd like to make the decision before year end whether we move forward with the Fortis design to a CE mark or whether we decide to wait for a next generation that incorporates a number of enhancements to move to a CE mark," Edwards chairman and CEO Michael Mussallem said on an April earnings call. "And we haven't made that determination yet. We'd like to get some more clinical experience. But I do think that we'll make that decision yet this year."
Edwards was off 2% in early trading after the news of the paused Fortis trial.
- here is the release