Edwards Lifesciences Implants First Fortis Mitral Transcatheter Heart Valves

Irvine, Calif.-based Edwards Lifesciences Corporation’s Fortis mitral transcatheter heart valve has been successfully implanted into the first three patients, the company reports. The implantation procedures were performed in February and March by the heart team at St. Thomas’ Hospital in London, United Kingdom.

“These first patients had severe mitral valve disease and many risk factors that prevented them from undergoing surgery,” said Vinayak Bapat, FRCS CTh, consultant cardiothoracic surgeon at St. Thomas’ Hospital. “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. 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.”

Bapat and the hospital’s Heart Team—also led by Martyn Thomas, MD, FRCP, clinical director of cardiovascular services, and Jane Hancock, MD, PhD, MRCP, consultant cardiologist specializing in imaging—are experienced in less invasive valve procedures, including transcatheter aortic valve replacement.

“Following the prolonged delay of first-in-man (FIM) implants due to regulatory approval timing, we view today’s announcement as a positive step forward for Edwards Lifesciences and a critical milestone in what has historically been a difficult pipeline project given the complexity of the disease and the intricacies of the device,” commented Leerink analysts. “We view TMVR (transcatheter mitral heart valve) as a key driver of Edwards’ long-term growth story but acknowledge that we are still a long way from commercialization, with a likely rigorous clinical trial program ahead that makes it unlikely the product comes to market for at least another 5-7 years. In the near-term, we expect that the initial outcomes from these FIM implants could be presented at medical meetings over the next year or so and will be an important driver of Edwards’ stock performance.”

The Fortis transcatheter mitral valve features Edwards’ treated bovine pericardial tissue, a cloth-covered self-expanding frame designed to minimize paravalvular leak and an anatomical anchoring system. This series of implants is being performed via a transapical (through an incision in the chest between the ribs) approach to allow direct surgical access to the mitral valve complex.

“We believe 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,” said Michael A. Mussallem, Edwards’ chairman and CEO. “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.”

Edwards expects these cases to be reviewed in the normal course at future medical meetings. The company’s transcatheter mitral valve, which utilizes a transapical approach that a surgeon performs through a small incision in the ribs, is not for sale in any country.

Leerink analysts also noted that this trial will be “highly educational” for Edwards, as there are currently no good TMVR animal models.

“…Because Fortis utilizes a larger-sized transapical delivery and a large valve, Edwards isn’t likely to go straight into CE mark trials but will instead wait until there is data in at least 10 patients,” analysts continued. “Most likely, there will be further product tweaks ahead based on experience and outcomes with these first 10 implants, but we expect this phase of development to move rather quickly. We believe it’s possible that Edwards could enter CE mark trials with Fortis in late 2014/early 2015 based on this timeline.”

Edwards Lifesciences makes heart valves and hemodynamic monitoring products.