Edwards Lifesciences announced the successful completion of 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, UK.
“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,” says Vinayak “Vinnie” Bapat, consultant cardiothoracic surgeon, St. Thomas’ Hospital in London. “We’re very proud to play a role in advancing the investigation of this developing therapy, which has the potential to fulfil an unmet need among many patients.” Bapat and the hospital’s Heart Team – also led by Martyn Thomas, clinical director of cardiovascular services, and Jane Hancock, consultant cardiologist specialising in imaging – are experienced in less invasive valve procedures, including transcatheter aortic valve implantation (TAVI).
The Fortis transcatheter mitral valve features Edwards’ most advanced, treated bovine pericardial tissue. It features a cloth-covered self-expanding frame designed to minimise paravalvular leak, and a unique anatomical anchoring system. This series of implants is being performed via a transapical approach to allow direct surgical access to the mitral valve complex.
Edwards expects these cases to be reviewed in the normal course at future medical meetings. The company’s transcatheter mitral valve, which utilises a transapical approach that a surgeon performs through a small incision in the ribs, is not for sale in any country.