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Edwards Undeterred By Latest Speed Bump In Transcatheter Mitral Valve Program

Edwards has temporarily paused the FORTIS clinical program evaluating a new transcatheter mitral valve to resolve valve thrombosis issues that emerged in the first 20 patients.

Edwards Lifesciences Corp. has voluntarily paused enrollment in the clinical trial program for its Fortis self-expanding transcatheter mitral valve technology in order to study valve thrombosis problems that appeared in the early trials of the device, the company said May 19.

"While it is still very early in the program, and we anticipated that optimizing this therapy would be challenging, we are continuing to learn which patients may benefit," the company said

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