Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability
NYON,
Edwards’ SAPIEN 3 Ultra RESILIA 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.
“Today’s patients are living longer, more active lives, with high expectations for their health and quality of life, so lifetime management of heart valve disease, starting with the first valve, is increasingly important,” said Flavio Ribichini, professor of cardiovascular medicine at the
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.*
RESILIA tissue is already used in the world’s leading surgical aortic valve, the Edwards INSPIRIS RESILIA valve. Recent data on the RESILIA tissue from the 7-year COMMENCE Study showed encouraging results with low rates of structural valve deterioration (99.3% freedom from structural valve deterioration), clinically stable gradients and freedom from reoperation (97.2%).‡
“RESILIA tissue is the result of nearly 20 years of research and development and is a prime example of Edwards’ continued focus on delivering technology that puts patients first,” said
In addition to its anti-calcification properties, RESILIA tissue allows the valve to be stored under dry packaging conditions, facilitating ease of use. Today, 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.
Notes to Editors
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† The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the
‡ Beaver T, Bavaria J, Griffith B, et al. Seven-Year Outcomes Following Aortic Valve Replacement with a Novel Tissue Bioprosthesis. J Thorac Cardiovasc Surg. 2023 Sep 29:S0022-5223(23)00873-5.
§ Stinis CT, Abbas AE, Teirstein P, et al. Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in
No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.
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