The implants, in February and March, involved patients too sick to risk open heart surgery, according to a press release.
It’s good news for Edwards, which last month said a regulatory hiccup had delayed the start of its mitral valve program. 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, according to the release.
"We believe mitral valve disease is under-treated worldwide, and there is a particular need among patients who are too high risk to benefit from traditional surgical options," chairman & CEO Michael Mussallem said in prepared remarks. "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. 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."
"These first patients had severe mitral valve disease and many risk factors that prevented them from undergoing surgery. After careful evaluation and close consultation with the patients and their families, we determined that this therapy could potentially extend and improve their lives. At this early stage, we are very pleased with the initial recoveries of these patients," added Dr. Vinayak "Vinnie" Bapat of St. Thomas’ Hospital. "We’re very proud to play a role in advancing the investigation of this developing therapy, which has the potential to fulfill an unmet need among many patients."