Edwards Lifesciences has now obtained European regulatory approval to market its new SAPIEN 3 transcatheter aortic heart valve. The new device builds on the previous generations of Edwards’ popular SAPIEN valves by having a smaller delivery size and adding a layer of fabric around the structural frame of the valve. This fabric skirt helps prevent paravalvular leakage, and initial trials of the device on human subjects have so far verified that significant leaks are eliminated with the SAPIEN 3.
The third generation of Edwards’ valve is yet to receive US Food and Drug Administration clearance, which will be based on results from the ongoing PARTNER II clinical trial.
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.”