Edwards Pauses Enrollment in Early Stage Fortis Mitral Valve Program

May 19, 2015—Edwards Lifesciences Corporation advised that the company, in consultation with trial investigators, has voluntarily implemented a temporary pause on enrollment in the clinical program for its investigational Fortis transcatheter mitral valve. 

Edwards stated that evidence of valve thrombosis was observed, which the company believes warrants additional investigation. Edwards is working closely with the trial investigators and heart teams to gather additional information in this early study of transcatheter mitral valve replacement therapy. To date, more than 20 patients globally have been treated with the Fortis valve, all of whom had symptomatic mitral regurgitation and were either compassionate cases or in one of Edwards’ high-risk registries. 

"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," said Edwards in its statement. "We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy."