Edwards Lifesciences has successfully completed the first three human implants of its FORTIS mitral transcatheter heart valve, which were performed in February and March by the Heart Team at St. Thomas' Hospital in London.
The Fortis valve is made of bovine heart tissue and a cloth-covered, self-expanding frame designed to minimize the paravalvular leakage that plagued early transcatheter valve technologies.
This series of implants is being performed via a transapical approach to allow direct surgical access to the mitral valve complex.
Edwards chairman and CEO Michael A Mussallem said the company believes mitral valve disease is undertreated worldwide, and there is a particular need among patients who are too high risk to benefit from traditional surgical options.
"We’d like to thank the Heart Team at St. Thomas’ Hospital for their dedication to providing outstanding patient care to these patients who faced dismal prognoses and otherwise would have gone untreated," Mussallem added.
"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."
The company’s transcatheter mitral valve utilizes a transapical approach that a surgeon performs through a small incision in the ribs and is currently not for sale in any country.