Edwards temporarily halts transcatheter mitral valve replacement clinical program

Edwards Lifesciences announced that it has implemented a temporary pause in enrollment in its Fortis clinical program for development of a transcatheter mitral valve replacement system.

“We observed evidence of valve thrombosis that we believe warrants additional investigation,” the company stated in a press release. “We are working closely with the trial investigators and heart teams to gather additional information in this early study of transcatheter mitral valve replacement therapy.”

As of this writing, more than 20 patients have received the transcatheter mitral valve (Fortis), all of whom had symptomatic mitral regurgitation and were compassionate cases or enrolled in a high-risk registry, according to the release.

"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 stated in the release. “We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy.”

The valve has not yet been approved for sale in the United States or anywhere else.