Edwards Receives European Approval for Advanced SAPIEN 3 Valve
IRVINE, CA, January 27, 2014 -- Edwards Lifesciences Corporation today announced that it has received CE Mark in Europe and is initiating the launch of its most advanced transcatheter aortic valve, the Edwards SAPIEN 3 valve.
The new valve has an outer skirt — a cuff of fabric surrounding the valve frame — providing a seal to address paravalvular leak. The effectiveness of this solution is supported by the limited clinical experience(1, 2), as detailed in two first-in-human feasibility studies, which demonstrated that significant paravalvular leak was eliminated during transcatheter aortic valve implantation (TAVI).
The SAPIEN 3 valve is the only commercial transcatheter heart valve that can be delivered through a low-profile 14 French expandable sheath (eSheath), which has shown through early clinical experience a low rate of complications(1, 2). The valve can be implanted through multiple approaches: transfemoral, transapical or transaortic. Once implanted, the discreet valve anchors in the aortic annulus.
In the United States, the Edwards SAPIEN 3 valve is an investigational device being studied in the PARTNER II Trial and is not yet available for sale in the country.
(1) Binder RK, Rodés-Cabau J, Wood DA, et al. Transcatheter Aortic Valve Replacement With the SAPIEN 3: A New Balloon-Expandable Transcatheter Heart Valve. J Am Coll Cardiol Intv. 2013;6(3):293-300. doi:10.1016/j.jcin.2012.09.019.
(2) Dvir D, Barbanti M, De Larochelliere R, et al. TCT-787 Preliminary Clinical Experience using the SAPIEN 3 device. J Am Coll Cardiol. 2013;62(18_S1):B239. doi:10.1016/j.jacc.2013.08.1539.