Edwards Lifesciences, a provider of heart valves and haemodynamic monitoring, has received CE mark for the 29 millimetre version of its Sapien XT transcatheter aortic heart valve.
The valve will be available with the Ascendra transapical delivery system for implantation through a small incision between the ribs, and this new offering increases the valve portfolio to three sizes.
The Edwards Sapien XT valve builds upon the features of the Edwards Sapien valve, incorporating a tissue leaflet design that is modelled on Edwards’ surgical aortic tissue valves – which have clinically proven durability – and a cobalt chromium frame that provides improved radial strength.
The Edwards Sapien XT valve has been used widely by clinicians throughout Europe since its commercial launch in the region in 2010, and is an investigational device in the US that is being studied in the Partner II Trial, a randomized controlled study.
Edwards’ transcatheter valve replacement corporate vice president Larry Wood said they knew it was important to provide patients with a 29mm valve, and they are pleased that they can now help even more patients in need.