Edwards Lifesciences, a heart valve company, has received CE Mark approval for European commercial sales of its RetroFlex 3 transfemoral delivery system for its Sapien transcatheter heart valve.
The RetroFlex 3 delivery system is designed to control the navigation of the valve, through the incorporation of the valve expansion balloon directly into the delivery system's flexible tip, the company said. The new design also facilitates the crossing of the patient's native aortic valve, which in this population is calcified as a result of severe aortic stenosis, according to the St-Prex, Switzerland-based Edwards.
The Edwards Sapien transcatheter heart valve with the RetroFlex 3 transfemoral and Ascendra transapical delivery systems is approved for commercial sale in Europe. In the U.S., the Edwards Sapien valve is an investigational device that is being studied in the PARTNER (Placement of AoRTic traNscathetER valves) randomized clinical trial, and is not available for sale.