The Transcatheter Aortic Heart Valve landscape is a dynamic affair with more regulatory and IP twists and turns than the most tortuous anatomy. Two weeks ago Medtronic finally got approval to market its CoreValve device in the US. Now its rival front-runner, Edwards Lifesciences Corporation has received CE Mark approval for the SAPIEN 3 valve. European launch of what Edwards is calling its most advanced transcatheter aortic valve is imminent.
The SAPIEN 3 valve builds upon Edwards’ decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. 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.
“European physicians have been eagerly awaiting the launch of the Edwards SAPIEN 3 valve, and we are very excited to make it available today. It has a unique design intended to provide a simpler procedure, along with fewer post-procedural complications and a faster recovery for patients,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “Based on our clinical leadership in transcatheter heart valves, we believe the SAPIEN 3 valve’s characteristics and procedural refinements have the potential to transform TAVI for both physicians and patients.”
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.
Source: Edwards Lifesciences Corporation