On 18 June 2012, Edwards Lifesciences announced that it has received the CE mark in Europe for the Ascendra+ system for the delivery of the Edwards Sapien XT transcatheter heart valve. It is the first delivery system optimised for both transapical and transaortic implantation of a transcatheter heart valve.
The CE mark includes a new transaortic indication for delivery of the valve through mini-sternotomy or mini-thoracotomy, after which the valve is then implanted through a small incision in the aorta.
“Edwards’ enhanced delivery system, with new features that aid in optimising valve positioning during transapical and now transaortic implantation, provides heart teams in Europe with an even broader array of options to ensure patients are treated with the technique best suited to their anatomical needs,” said Vinayak Bapat, consultant cardiothoracic surgeon at Guys and St Thomas’ Hospital in London, UK. “This is a meaningful development for clinicians and the patients in their care who suffer with severe, symptomatic aortic stenosis.” Bapat provides paid consulting services to Edwards for education, and research and development of heart valve technologies.
The Ascendra+ System is designed to enhance handling and control during valve positioning. The Edwards Sapien XT Valve and the Ascendra+ delivery system are investigational devices not yet available commercially in the United States.