Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability - Seite 2

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. Curtiss Stinis presented compelling results from a large, real-world study (10,314 patients), based on US TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. A study of the SAPIEN 3 Ultra RESILIA valve found lower rates of paravalvular leak (PVL) 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.

Notes to Editors

* De La Fuente AB, et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.

^† 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 Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

^‡ 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 the United States. JACC Cardiovasc Interv. 2024 Apr 22;17(8):1032-1044.

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.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on LinkedIn and X.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, Edwards SAPIEN 3 Ultra RESILIA, Edwards INSPIRIS RESILIA, INSPIRIS RESILIA, INSPIRIS, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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The Edwards Lifesciences Stock at the time of publication of the news with a fall of -0,87 % to 85,09EUR on NYSE stock exchange (09. Mai 2024, 01:00 Uhr).