With this approval, the company is initiating the European launch of its most advanced transcatheter aortic valve.

The Sapien 3 (TAV) valve features and outer skirt, a cuff of fabric surrounding the valve frame, to provide a seal to address paravalvular leak. The device can be delivered through a low-profile 14-French expandable sheath.

The valve can be implanted through transfemoral, transapical or transaortic approaches. Once implanted, the discreet valve anchors in the aortic annulus.

In the two first-in-human feasibility studies, the device demonstrated elimination of significant paravalvular leak during transcatheter aortic valve implantation.

Edwards transcatheter heart valves corporate vice president Larry L Wood noted the European physicians have been eagerly awaiting the launch of the Edwards SAPIEN 3 valve, and the company is 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.

"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," Wood added.

Edwards SAPIEN 3 valve is an investigational device in the US and is not yet available for sale in the country. The device is being studied in the PARTNER II trial.

Image: Edwards’ SAPIEN transcatheter heart valve Model 9000TFX and accessories. Photo: Courtesy of US Food and Drug Administration.