Edwards Lifesciences Stops Enrollment in Heart Valve Trial

Irvine, Calif.-based Edwards Lifesciences Corporation has halted enrollment in its Fortis clinical trial which was evaluating the Fortis heart valve. Subjects were developing blood clots, and company officials said they felt the occurrences warranted further investigation.

To date, the trial has treated more than 20 patients worldwide, all of whom had symptomatic mitral regurgitation and who were either compassionate cases or in one of Edwards Lifesciences’ high-risk registries.

The company reports it is working closely with trial investigators and Heart Teams to gather additional information in this early study of transcatheter mitral valve replacement therapy.

Edwards Lifesciences makes technology for heart valves and hemodynamic monitoring.