Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrates Continued Excellent Outcomes for Patients in Real World Data
Edwards Lifesciences (NYSE: EW) announced one-year data showing exceptional performance of its SAPIEN 3 Ultra RESILIA valve. Analysis of over 9,000 propensity-matched patients revealed superior outcomes compared to earlier valve generations, with extremely low mortality, low reintervention rates, and no paravalvular leak in 84.4% of cases. Patients experienced significant quality of life improvements with an average 31-point increase in KCCQ score and brief one-day hospital stays, with 93% discharged home. The study population had an average STS score of 3.6 and average age of 77.
Edwards Lifesciences (NYSE: EW) ha annunciato dati a un anno che mostrano un eccezionale performance della sua valvola SAPIEN 3 Ultra RESILIA. L'analisi di oltre 9.000 pazienti abbinati per propensione ha rivelato risultati superiori rispetto alle generazioni di valvole precedenti, con una mortalità estremamente bassa, tassi di reintervento ridotti e nessuna fuga paravalvolare nel 84,4% dei casi. I pazienti hanno sperimentato significativi miglioramenti della qualità della vita con un aumento medio di 31 punti nel punteggio KCCQ e brevi degenze ospedaliere di un giorno, con il 93% dimesso a casa. La popolazione dello studio presentava un punteggio STS medio di 3,6 e un'età media di 77 anni.
Edwards Lifesciences (NYSE: EW) anunció datos de un año que muestran un rendimiento excepcional de su válvula SAPIEN 3 Ultra RESILIA. El análisis de más de 9,000 pacientes emparejados por propensión reveló resultados superiores en comparación con generaciones anteriores de válvulas, con una mortalidad extremadamente baja, bajos índices de reintervención y ninguna fuga paravalvular en el 84.4% de los casos. Los pacientes experimentaron mejoras significativas en la calidad de vida con un aumento promedio de 31 puntos en la puntuación KCCQ y estancias hospitalarias breves de un día, con un 93% dados de alta para regresar a casa. La población del estudio tenía una puntuación STS promedio de 3.6 y una edad promedio de 77 años.
에드워즈 라이프사이언스 (NYSE: EW)는 SAPIEN 3 Ultra RESILIA 밸브의 뛰어난 성능을 보여주는 1년 데이터 발표했습니다. 9,000명 이상의 성향 일치 환자 분석 결과, 이전 밸브 세대와 비교하여 매우 낮은 사망률, 재개입률 및 84.4%의 경우에서 패러밸브 누수가 없는 우수한 결과를 확인했습니다. 환자들은 KCCQ 점수에서 평균 31점 향상과 1일 간의 짧은 병원 입원을 경험했으며, 93%가 집으로 퇴원했습니다. 연구 인구의 평균 STS 점수는 3.6, 평균 연령은 77세였습니다.
Edwards Lifesciences (NYSE: EW) a annoncé des données d'un an montrant des performances exceptionnelles de sa valve SAPIEN 3 Ultra RESILIA. L'analyse de plus de 9 000 patients appariés pour propension a révélé des résultats supérieurs par rapport aux générations de valves antérieures, avec une mortalité extrêmement faible, de faibles taux de réintervention et aucune fuite paravalvulaire dans 84,4 % des cas. Les patients ont connu des améliorations significatives de la qualité de vie avec une augmentation moyenne de 31 points dans le score KCCQ et de brèves séjours hospitaliers d'un jour, 93 % ayant été renvoyés chez eux. La population de l'étude avait un score STS moyen de 3,6 et un âge moyen de 77 ans.
Edwards Lifesciences (NYSE: EW) hat Daten für ein Jahr veröffentlicht, die eine außergewöhnliche Leistung ihres SAPIEN 3 Ultra RESILIA Ventils zeigen. Die Analyse von über 9.000 gleichgestellten Patienten ergab überlegene Ergebnisse im Vergleich zu früheren Ventilgenerationen, mit einer extrem niedrigen Sterblichkeit, niedrigen Reinterventionsraten und keinem paravalvulären Leck in 84,4% der Fälle. Die Patienten erlebten signifikante Verbesserungen der Lebensqualität mit einem durchschnittlichen Anstieg von 31 Punkten im KCCQ-Score und kurzen Krankenhausaufenthalten von nur einem Tag, wobei 93% nach Hause entlassen wurden. Die Studienpopulation hatte einen durchschnittlichen STS-Score von 3,6 und ein Durchschnittsalter von 77 Jahren.
- Superior clinical outcomes compared to previous valve generations
- 84.4% of cases showed no paravalvular leak
- 31-point average increase in quality of life scores
- 93% of patients discharged to home after just one day
- Larger effective orifice areas and lower echo-derived gradients across all valve sizes
- None.
Insights
The real-world data from over 9,000 matched patients demonstrates significant clinical advantages of the SAPIEN 3 Ultra RESILIA valve. Key performance metrics show excellent outcomes with 84.4% of cases having no paravalvular leak, improved survival rates and larger effective orifice areas. The 31-point increase in KCCQ score indicates substantial quality of life improvements, while the one-day hospital stay suggests efficient recovery.
Most notably, the data shows superior performance compared to previous SAPIEN generations, particularly in low-risk patients where long-term durability is crucial. The average STS score of 3.6 and high home discharge rate of 93% indicate the valve's effectiveness across diverse patient populations. This real-world validation strengthens Edwards' market position in the TAVR space and suggests potential for market share expansion, especially in younger, lower-risk patients.
An analysis of data from more than 9,000 propensity-matched patients in the STS/ACC TVT Registry1 demonstrated that those who received Edwards’ newest generation SAPIEN 3 Ultra RESILIA valve experienced outstanding one-year outcomes that continuously surpassed recipients of the earlier generation SAPIEN 3 and SAPIEN 3 Ultra valves. Patients receiving the SAPIEN 3 Ultra RESILIA valve experienced extremely low mortality, low rates of reintervention, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in
“These strong, real-world data continue to demonstrate that patients treated with a SAPIEN valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards SAPIEN valve platform and more than 10 years of clinical experience with the RESILIA tissue.”
Patients in the SAPIEN 3 Ultra RESILIA valve cohort, who had an average STS score of 3.6 and average age of 77, experienced meaningful quality of life benefits with a clinically significant average 31-point increase in KCCQ2 score and one-day length of hospital stay with
"This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved 1-year survival after TAVR versus prior generation valves, given it reduces mild or greater paravalvular leak,” said Gilbert Tang, MD, MSc, MBA, Surgical and Academic Director of the Structural Heart Program for the Mount Sinai Health System and Professor and Vice-Chair of Innovation in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai. “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”
Dr. Tang is a consultant for Edwards Lifesciences.
1 The STS/ACC TVT Registry is a collaboration between the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC).
2 The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item survey that measures the impact of heart failure on a patient's quality of life, symptoms, and physical function.
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 Mr. Wood and statements regarding expected patient outcomes and product benefits, performance of the technologies, 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, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, 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: Howard Wright, 949-250-2790
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Source: Edwards Lifesciences Corporation
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