A novel heart valve for transcatheter aortic valve implantation (TAVI) treats high-risk and inoperable patients suffering from severe symptomatic aortic stenosis.

The Edwards SAPIEN XT transcatheter heart valve series provide optimal hemodynamic performance thanks to a low-profile, rigid, expandable cobalt chromium frame with high radial strength, which maintains 96% circularity. The inset bovine pericardial tissue valve is composed of three leaflets designed to match and enhance stress distribution thanks to a uniform coaptation. Sustained valve performance is optimized by the use of the Carpentier-Edwards ThermaFix process for leaflet manufacture, which minimizes the risk of calcification and adds durability.

Frame height takes into account surrounding cardiac anatomy, minimizing risk of atrioventricular (AV) block, disruption of mitral valve function, and interference with coronary ostia. The series includes annulus size range of 18–27 mm, with a 29 mm valve size for patients with a large native annulus. All XT valve sizes can be placed using the NovaFlex+ transfemoral and the Ascendra+ transapical and transaortic delivery systems. The Edwards SAPIEN XT transcatheter heart valve is a product of Edwards Lifesciences (Irvine, CA, USA), and has been approved by the US Food and Drug Administration (FDA).

“Clinicians have demonstrated their confidence in the SAPIEN valves by making them the market-leading transcatheter valves, and this approval provides greater options for US patients who can benefit from the substantial enhancements in this proven platform,” said Larry Wood, corporate vice president for transcatheter heart valves at Edwards Lifesciences. “We look forward to heart teams across America transforming the lives of even more patients with this advanced transcatheter valve.”

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