Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability
Edwards Lifesciences has launched the SAPIEN 3 Ultra RESILIA valve in Europe, incorporating breakthrough RESILIA tissue technology for enhanced durability. The valve received CE Mark for patients with heart valve disease, with RESILIA tissue offering potential for extended durability. The valve aims to improve quality of life and future treatment options with lower rates of paravalvular leak and larger effective orifice areas. The technology is backed by 7-year COMMENCE Study data showing excellent outcomes. RESILIA tissue is a result of 20 years of research, indicating Edwards' focus on patient-centric technology.
The SAPIEN 3 Ultra RESILIA valve offers enhanced durability with RESILIA tissue technology.
Lower rates of paravalvular leak and larger effective orifice areas are observed with the valve, improving patient outcomes.
Data from the 7-year COMMENCE Study shows promising results, with high freedom from structural valve deterioration and low rates of reoperation.
RESILIA tissue, with advanced anti-calcification technology, allows for extended durability and ease of use with dry packaging conditions.
The valve's launch emphasizes Edwards Lifesciences' commitment to patient-first technology and lifetime management of valve disease.
No clinical data are available yet to evaluate the long-term impact of RESILIA tissue in patients.
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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 University of Verona. “SAPIEN 3 Ultra RESILIA gives these patients a promising option, as RESILIA tissue’s calcium-blocking technology addresses structural valve deterioration, one of the primary causes of reintervention following heart valve replacement.”
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 (
“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 Gregory Servotte, senior vice president of transcatheter heart valves EU at Edwards Lifesciences. “Latest data emphasize the value of RESILIA tissue in the lifetime management of valve disease.‡§ The SAPIEN 3 Ultra RESILIA valve utilizes this technology with the aim of improving quality of life, offering sustainable long-term patient outcomes and making future treatment options possible.”
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 ≥
‡ 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.
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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Media Contact:
Rowan Unsworth, +41 (0)79 564 20 82, rowan_unsworth@edwards.com
Source: Edwards Lifesciences Corporation
FAQ
<p>What is the SAPIEN 3 Ultra RESILIA valve?</p>
The SAPIEN 3 Ultra RESILIA valve is a transcatheter aortic heart valve incorporating Edwards Lifesciences' RESILIA tissue technology for enhanced durability.
<p>What benefits does the SAPIEN 3 Ultra RESILIA valve offer?</p>
The valve offers lower rates of paravalvular leak, larger effective orifice areas, and improved patient outcomes due to its advanced technology.
<p>What data supports the efficacy of RESILIA tissue?</p>
Data from the 7-year COMMENCE Study demonstrates high freedom from structural valve deterioration and low rates of reoperation, showcasing the effectiveness of RESILIA tissue.
<p>How does RESILIA tissue contribute to extended durability?</p>
RESILIA tissue, with advanced anti-calcification technology, allows for extended durability of the valve by addressing structural valve deterioration.
