TMVI: Good early data on Edwards Lifesciences’ Fortis valve

A small, early feasibility study showed good results in high-risk patients treated with the Fortis mitral valve replacement made by Edwards Lifesciences (NYSE:EW).

Data from the 3-patient study, published this month in the Journal of the American College of Cardiology, showed successful implantation of the Fortis transcatheter mitral valve implant with no major complications. Echocardiograms at discharge showed “trace residual” mitral regurgitation in 2 patients and none in the 3rd, according to the study, “Initial Experience of Transcatheter Mitral Valve Replacement With a Novel Transcatheter Mitral Valve.”

After 3 months valve function was unchanged and ECGs and CT scans showed no structural failures, the researchers wrote. All patients showed improved functional status, exercise capacity and quality of life, they wrote.

At 6 months all patients were alive with no hospital readmissions for heart failure and New York Heart Assn. classificationsof Class II or lower, according to the study.

“TMVI with this valve is feasible and is associated with good outcomes. Optimal valve functional results were obtained acutely and were sustained at 6-month follow-up in all patients. Further studies with a larger number of patients and longer follow-up are warranted,” the researchers wrote.

Edwards, which in May paused the Fortis trial after discovering blood clots in some of the 20 patients implanted with the device, said in July that the trial was back on track after it agreed to make changes to the study’s protocol.

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