Edwards Lifesciences announces successful first human implantations of Fortis valve

Edwards Lifesciences Corp. announced the first three human implants of its Fortis mitral transcatheter heart valve at St. Thomas’ Hospital in London.

The valve features an anatomical anchoring system and a cloth-covered, self-expanding frame intended to minimize the incidence of paravalvular leak, according to a press release. The valve is implanted via a transapical approach.

The initial three patients had severe mitral valve disease and several risk factors for surgery, according to Vinayak Bapat, FRCS, CTh, consultant cardiothoracic surgeon at St. Thomas’ Hospital. “At this early stage, we are very pleased with the initial recoveries of these patients,” Bapat said in the release.

Edwards anticipates these cases will be reviewed at future medical meetings.

“… This early experience provides a very important opportunity for learning in this challenging anatomy. Although durable success will not be known without significantly more experience and longer-term follow-up, we are excited about this potential opportunity that we believe may be very meaningful for patients,” Michael A. Mussallem, chairman and CEO of Edwards Lifesciences, said in the release.

The Fortis valve is currently not for sale in any country.