Eight-Year Data Confirm Long-Term Durability of Edwards’ RESILIA Tissue
Edwards Lifesciences (NYSE: EW) announced groundbreaking eight-year data demonstrating superior outcomes for patients receiving aortic surgical valves with their proprietary RESILIA tissue technology compared to non-RESILIA tissue bioprosthetic valves.
The study of 947 patients showed remarkable durability metrics, with 99.3% freedom from structural valve deterioration (SVD) in the RESILIA group versus 90.5% in the non-RESILIA group. Additionally, freedom from reoperation due to SVD was 99.2% for RESILIA tissue versus 93.9% for non-RESILIA tissue.
RESILIA tissue is currently utilized across Edwards' surgical and transcatheter platforms, including INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA, and SAPIEN 3 Ultra RESILIA valves. Over 450,000 patients worldwide have been treated with Edwards' surgical or TAVR valves featuring RESILIA tissue, marking a significant milestone in structural heart disease treatment.
Edwards Lifesciences (NYSE: EW) ha annunciato dati rivoluzionari a otto anni che dimostrano risultati superiori per i pazienti sottoposti a interventi chirurgici con valvole aortiche realizzate con la loro esclusiva tecnologia tessutale RESILIA, rispetto alle valvole bioprotesiche non RESILIA.
Lo studio su 947 pazienti ha evidenziato metriche di durabilità straordinarie, con una libertà dal deterioramento strutturale della valvola (SVD) del 99,3% nel gruppo RESILIA contro il 90,5% nel gruppo non RESILIA. Inoltre, la libertà da reinterventi dovuti a SVD è stata del 99,2% per il tessuto RESILIA contro il 93,9% per quello non RESILIA.
Il tessuto RESILIA è attualmente utilizzato nelle piattaforme chirurgiche e transcatetere di Edwards, inclusi i dispositivi INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA e SAPIEN 3 Ultra RESILIA. Oltre 450.000 pazienti nel mondo sono stati trattati con valvole chirurgiche o TAVR di Edwards contenenti tessuto RESILIA, segnando un traguardo importante nel trattamento delle malattie strutturali del cuore.
Edwards Lifesciences (NYSE: EW) anunció datos revolucionarios a ocho años que demuestran resultados superiores para pacientes que recibieron válvulas aórticas quirúrgicas con su exclusiva tecnología tisular RESILIA, en comparación con válvulas bioprotésicas sin tejido RESILIA.
El estudio con 947 pacientes mostró métricas de durabilidad notables, con una libertad del 99.3% de deterioro estructural de la válvula (SVD) en el grupo RESILIA frente al 90.5% en el grupo sin RESILIA. Además, la libertad de reoperación por SVD fue del 99.2% para tejido RESILIA frente al 93.9% para tejido sin RESILIA.
El tejido RESILIA se utiliza actualmente en las plataformas quirúrgicas y transcatéter de Edwards, incluyendo las válvulas INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA y SAPIEN 3 Ultra RESILIA. Más de 450,000 pacientes en todo el mundo han sido tratados con válvulas quirúrgicas o TAVR de Edwards que contienen tejido RESILIA, marcando un hito importante en el tratamiento de las enfermedades estructurales del corazón.
Edwards Lifesciences (NYSE: EW)는 독자적인 RESILIA 조직 기술을 적용한 대동맥 수술용 판막이 비-RESILIA 조직 생체판막에 비해 환자에게 우수한 결과를 보인다는 획기적인 8년간의 데이터를 발표했습니다.
947명의 환자를 대상으로 한 연구에서 RESILIA 그룹은 구조적 판막 퇴화(SVD)로부터 99.3%의 자유도를 기록한 반면, 비-RESILIA 그룹은 90.5%에 그쳤습니다. 또한 SVD로 인한 재수술 자유도는 RESILIA 조직이 99.2%, 비-RESILIA 조직은 93.9%였습니다.
RESILIA 조직은 현재 Edwards의 수술용 및 경피적 플랫폼에서 사용되고 있으며, INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA, SAPIEN 3 Ultra RESILIA 판막이 포함됩니다. 전 세계 45만 명 이상의 환자가 RESILIA 조직이 적용된 Edwards의 수술용 또는 TAVR 판막으로 치료받아 구조적 심장 질환 치료에 중요한 이정표를 세웠습니다.
Edwards Lifesciences (NYSE : EW) a annoncé des données révolutionnaires sur huit ans démontrant des résultats supérieurs pour les patients recevant des valves aortiques chirurgicales avec leur technologie tissulaire propriétaire RESILIA comparées aux valves bioprothétiques sans tissu RESILIA.
Cette étude menée sur 947 patients a révélé des indicateurs de durabilité remarquables, avec une liberté de 99,3 % de détérioration structurelle de la valve (SVD) dans le groupe RESILIA contre 90,5 % dans le groupe non RESILIA. De plus, la liberté de réintervention liée à la SVD était de 99,2 % pour le tissu RESILIA contre 93,9 % pour le tissu non RESILIA.
Le tissu RESILIA est actuellement utilisé sur les plateformes chirurgicales et transcatheter d’Edwards, incluant les valves INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA et SAPIEN 3 Ultra RESILIA. Plus de 450 000 patients dans le monde ont été traités avec des valves chirurgicales ou TAVR d’Edwards intégrant le tissu RESILIA, marquant une étape importante dans le traitement des maladies cardiaques structurelles.
Edwards Lifesciences (NYSE: EW) hat bahnbrechende achtjährige Daten veröffentlicht, die überlegene Ergebnisse für Patienten zeigen, die aortale chirurgische Klappen mit ihrer proprietären RESILIA Gewebetechnologie erhalten, verglichen mit bioprothetischen Klappen ohne RESILIA-Gewebe.
Die Studie mit 947 Patienten zeigte bemerkenswerte Haltbarkeitswerte, mit 99,3% Freiheit von strukturellem Klappendefekt (SVD) in der RESILIA-Gruppe gegenüber 90,5% in der Nicht-RESILIA-Gruppe. Zudem lag die Freiheit von Reoperationen aufgrund von SVD bei RESILIA-Gewebe bei 99,2% gegenüber 93,9% bei Nicht-RESILIA-Gewebe.
RESILIA-Gewebe wird derzeit in Edwards chirurgischen und transkatheterbasierten Plattformen eingesetzt, darunter die INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA und SAPIEN 3 Ultra RESILIA Klappen. Weltweit wurden über 450.000 Patienten mit Edwards chirurgischen oder TAVR-Klappen mit RESILIA-Gewebe behandelt, was einen bedeutenden Meilenstein in der Behandlung struktureller Herzerkrankungen darstellt.
- Significantly superior 8-year durability data with 99.3% freedom from structural valve deterioration
- High freedom from reoperation rate of 99.2% demonstrates excellent product performance
- Large-scale adoption with over 450,000 patients treated worldwide
- Extensive product portfolio implementation across multiple valve platforms
- None.
Insights
Edwards' RESILIA tissue shows impressive 8-year durability data, strengthening its competitive position across surgical and transcatheter valve portfolios.
The newly released eight-year data for Edwards Lifesciences' proprietary RESILIA tissue represents a significant clinical validation for a technology that has been in development for over two decades. The propensity-matched study of 947 patients demonstrates compelling durability advantages with remarkably high freedom from structural valve deterioration (99.3% for RESILIA versus 90.5% for non-RESILIA, p<0.0001) and reoperation (99.2% versus 93.9%, p=0.0007).
These statistics aren't merely incremental improvements – they represent potentially transformative clinical outcomes in the valve space. The nearly 9% absolute difference in freedom from SVD at 8 years is particularly noteworthy as valve deterioration typically accelerates over time. This suggests the performance gap may widen further with extended follow-up.
The commercial implications are substantial as RESILIA tissue now forms the foundation of Edwards' entire valve portfolio spanning both surgical valves (INSPIRIS, KONECT, MITRIS) and transcatheter platforms (SAPIEN 3 Ultra RESILIA). With over 450,000 patients already treated with RESILIA tissue valves, this data reinforces Edwards' leadership position and creates a compelling narrative for physicians when selecting valve options.
The durability advantages demonstrated may be especially impactful for younger patients who have traditionally faced difficult choices between mechanical valves (requiring lifelong anticoagulation) and tissue valves (requiring potential reinterventions). By reducing reoperation rates, RESILIA potentially expands Edwards' addressable market while creating substantial healthcare economic benefits through avoided procedures.
Edwards' RESILIA tissue shows superior 8-year outcomes, validating their long-term R&D strategy and strengthening market leadership in heart valves.
This eight-year data represents a competitive moat-widening event for Edwards Lifesciences. The statistically significant improvements in both structural valve deterioration and reoperation rates validate Edwards' substantial investment in proprietary tissue technology. In the heart valve market, where product differentiation is increasingly challenging, Edwards now has compelling clinical evidence supporting a key technological differentiator across its entire valve portfolio.
The market penetration statistics are particularly telling – with 450,000 patients already treated globally, RESILIA has moved well beyond early adoption into mainstream clinical use. This installed base creates significant momentum that competitors will struggle to overcome, even if they develop similar technologies.
Edwards has executed a textbook platform strategy by leveraging RESILIA across multiple product lines, creating economies of scale in manufacturing while establishing consistent clinical messaging across surgical and transcatheter portfolios. The technology now bridges Edwards' traditional surgical valve business with its high-growth transcatheter segment, creating potential synergies in physician preference and patient management strategies.
From a competitive landscape perspective, this data may force other manufacturers to accelerate R&D investments in tissue technology or risk market share erosion. The timing is particularly advantageous as the structural heart market continues expanding with aging populations globally. By demonstrating superior durability through rigorous clinical evidence, Edwards strengthens its value proposition to both hospitals and payers who increasingly focus on long-term outcomes and total cost of care rather than device price alone.
For more than 65 years, Edwards has been the leader in heart valve innovations. To create a more durable heart valve, Edwards developed the RESILIA tissue technology more than two decades ago. Today, RESILIA tissue is used in a wide range of Edwards’ surgical and transcatheter platforms, including the INSPIRIS RESILIA aortic surgical valve, the KONECT RESILIA aortic surgical valve conduit, the MITRIS RESILIA mitral surgical valve and the SAPIEN 3 Ultra RESILIA transcatheter aortic heart valve. Edwards’ INSPIRIS RESILIA and SAPIEN 3 Ultra RESILIA valves are supported by extensive, long-term clinical evidence which is the result of three decades of innovation and expertise, leveraging the proven Carpentier-Edwards PERIMOUNT platform.
“These highly anticipated data provide strong clinical evidence of the excellent durability of RESILIA tissue in surgical valves,” said Tsuyoshi Kaneko, M.D., John M. Shoenberg Chair of Cardiovascular Disease, Chief of Cardiac Surgery at
Presented at the Heart Valve Society Annual Meeting, the study of 947 patients marks the first long-term, propensity-matched comparison between RESILIA tissue and non-RESILIA tissue surgical aortic valves. The RESILIA tissue data from the trial reported encouraging results through eight years, with low rates of structural valve deterioration (
“These data further validate the growing body of scientific evidence supporting the long-term durability, performance and significant patient benefits of our proprietary RESILIA tissue,” said Wayne Markowitz, Edwards’ senior vice president, surgical structural heart.
To date, more than 450,000 patients worldwide have been treated with Edwards’ surgical or TAVR valves with RESILIA tissue, reflecting its expanding role in the treatment of structural heart disease.
“With patients of all ages living longer and demanding higher quality of life, the importance of lifetime management has never been greater,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “This significant advancement in tissue technology highlights Edwards’ dedication to pioneering unique innovations and improving patient outcomes.”
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Messrs. Wood and Markowitz and statements regarding expected long-term patient benefits, clinical outcomes, objectives, and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS RESILIA, PERIMOUNT, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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Media Contact: Amy Meshulam, 949-250-4009
Investor Contact: Mark Wilterding, 949-250-6826
Source: Edwards Lifesciences Corporation
FAQ
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