Edwards Pauses Enrollment In Early Stage Mitral Program

IRVINE, Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that in consultation with trial investigators, the company has voluntarily implemented a temporary pause on enrollment in its FORTIS clinical program.  We observed evidence of valve thrombosis that we believe warrants additional investigation.

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.

To date, we have treated more than 20 patients globally with the FORTIS valve, all of whom had symptomatic mitral regurgitation and who were either compassionate cases or in one of our 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.  We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy.

The FORTIS valve is not approved for sale in any country.

Source:  Edwards Lifesciences