ASA Monitor September 2024, Vol. 88, 30.
Edwards launches the SAPIEN 3 Ultra RESILIA valve in Europe with technology to enhance durability
Edwards Lifesciences announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s RESILIA tissue technology, designed to extend the valve’s durability. The valve recently received CE Mark for use in patients with heart valve disease due to native calcific aortic stenosis at all levels of surgical risk or due to the failure of either a transcatheter or a surgical bioprosthetic valve who are judged to be at high or greater risk for open surgical therapy.
Edwards RESILIA is a bovine pericardial tissue treated with advanced anti-calcification technology that provides the potential to extend the durability of the SAPIEN 3 Ultra RESILIA valve.
In addition to its anti-calcification properties, the SAPIEN 3 Ultra RESILIA valve is the only transcatheter heart valve on the market with dry tissue storage.
At Cardiovascular Research Technologies (CRT) 2024, Dr. Curtiss Stinis presented compelling results from a large, real-world study (10,314 patients) of the SAPIEN 3 Ultra RESILIA valve that found lower rates of paravalvular leak at 30 days, lower echo-derived gradients, and larger effective orifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves.
Source: asamonitor.pub/3XYWcns
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