Edwards SAPIEN M3 Receives CE Mark, Becoming World’s First Transfemoral Transcatheter Mitral Valve Replacement System
Edwards Lifesciences (NYSE: EW) has received CE Mark approval for its SAPIEN M3 mitral valve replacement system, becoming the world's first transfemoral transcatheter mitral valve replacement therapy. The system is approved for treating patients with symptomatic moderate-to-severe or severe mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge therapy.
The SAPIEN M3 system utilizes a novel two-step procedure, delivering a dock that wraps around native mitral leaflets followed by valve placement. The system is delivered through a 29F outer diameter steerable guide sheath via the femoral vein. Built on Edwards' proven SAPIEN platform, which has been used in over 8,000 mitral procedures, the technology has shown substantial reduction in mitral regurgitation and improved quality of life.
Results from the ENCIRCLE pivotal trial are expected in late 2025, with a planned European Post-Market Clinical Follow-up Study tracking patients for up to five years.
Edwards Lifesciences (NYSE: EW) ha ricevuto l'approvazione CE per il suo sistema di sostituzione della valvola mitrale SAPIEN M3, diventando la prima terapia di sostituzione della valvola mitrale transfemorale transcatetere al mondo. Il sistema è approvato per trattare pazienti con rigurgito mitralico moderato-severo o severo sintomatico che non sono idonei per interventi chirurgici o terapia transcatetere edge-to-edge.
Il sistema SAPIEN M3 utilizza una nuova procedura in due fasi, fornendo un dock che avvolge le foglie mitraliche native seguito dall'inserimento della valvola. Il sistema viene somministrato attraverso un guanto guida manovrabile con diametro esterno di 29F tramite la vena femorale. Basata sulla comprovata piattaforma SAPIEN di Edwards, utilizzata in oltre 8.000 procedure mitraliche, la tecnologia ha mostrato una sostanziale riduzione del rigurgito mitralico e un miglioramento della qualità della vita.
I risultati del trial pivotale ENCIRCLE sono attesi per la fine del 2025, con uno studio clinico post-marketing europeo pianificato per monitorare i pazienti fino a cinque anni.
Edwards Lifesciences (NYSE: EW) ha recibido la aprobación del Marcado CE para su sistema de reemplazo de válvula mitral SAPIEN M3, convirtiéndose en la primera terapia de reemplazo de válvula mitral transcatéter transfemoral del mundo. El sistema está aprobado para tratar a pacientes con regurgitación mitral moderada a severa o severa sintomática que no son aptos para cirugía o terapia transcatéter edge-to-edge.
El sistema SAPIEN M3 utiliza un novedoso procedimiento en dos etapas, entregando un dock que envuelve las hojas mitrales nativas seguido de la colocación de la válvula. El sistema se entrega a través de una funda guía maniobrable de 29F de diámetro exterior a través de la vena femoral. Basada en la probada plataforma SAPIEN de Edwards, que se ha utilizado en más de 8,000 procedimientos mitrales, la tecnología ha mostrado una reducción sustancial en la regurgitación mitral y una mejora en la calidad de vida.
Se esperan resultados del ensayo pivotal ENCIRCLE para finales de 2025, con un estudio de seguimiento clínico post-comercialización europeo planificado para rastrear a los pacientes durante hasta cinco años.
에드워즈 라이프사이언스 (NYSE: EW)는 SAPIEN M3 승모판 교체 시스템에 대한 CE 마크 승인을 받았으며, 세계 최초의 경피적 대퇴동맥 승모판 교체 치료가 되었습니다. 이 시스템은 수술이나 경피적 엣지 투 엣지 치료에 적합하지 않은 증상이 있는 중등도에서 중증 승모판 역류 환자를 치료하는 데 승인되었습니다.
SAPIEN M3 시스템은 원주형 승모판을 감싸는 도크를 제공한 후 판막을 배치하는 새로운 두 단계 절차를 사용합니다. 이 시스템은 대퇴 정맥을 통해 29F 외경의 조작 가능한 가이드 시트를 통해 전달됩니다. 8,000건 이상의 승모판 시술에 사용된 에드워즈의 검증된 SAPIEN 플랫폼을 기반으로 하여, 이 기술은 승모판 역류의 상당한 감소와 삶의 질 개선을 보여주었습니다.
ENCIRCLE 주요 시험의 결과는 2025년 말에 예상되며, 최대 5년 동안 환자를 추적하는 유럽 시장 출시 후 임상 추적 연구가 계획되어 있습니다.
Edwards Lifesciences (NYSE: EW) a reçu l'approbation du marquage CE pour son système de remplacement de la valve mitrale SAPIEN M3, devenant ainsi la première thérapie de remplacement de valve mitrale par voie transfémorale et transcatheter au monde. Le système est approuvé pour traiter les patients présentant une régurgitation mitrale modérée à sévère ou sévère symptomatique qui ne sont pas adaptés à une chirurgie ou à une thérapie transcatheter edge-to-edge.
Le système SAPIEN M3 utilise une nouvelle procédure en deux étapes, livrant un dock qui entoure les feuillets mitraux natifs, suivi de la mise en place de la valve. Le système est délivré par une gaine de guidage maniable de 29F de diamètre extérieur via la veine fémorale. Basée sur la plateforme SAPIEN éprouvée d'Edwards, utilisée dans plus de 8 000 procédures mitrales, la technologie a montré une réduction substantielle de la régurgitation mitrale et une amélioration de la qualité de vie.
Les résultats de l'
Edwards Lifesciences (NYSE: EW) hat die CE-Kennzeichnung für sein SAPIEN M3 Mitralklappenersatzsystem erhalten und ist damit die erste transfemorale transkatheter Mitralklappenersatztherapie der Welt. Das System ist zur Behandlung von Patienten mit symptomatischer moderater bis schwerer oder schwerer Mitralklappeninsuffizienz zugelassen, die für eine Operation oder eine transkatheter edge-to-edge Therapie nicht geeignet sind.
Das SAPIEN M3-System verwendet ein neuartiges zweistufiges Verfahren, bei dem ein Dock geliefert wird, das die nativen Mitralklappenblätter umschließt, gefolgt von der Platzierung der Klappe. Das System wird über eine 29F Außendurchmesser steuerbare Führungsfolie über die Oberschenkelvene eingeführt. Basierend auf Edwards' bewährter SAPIEN-Plattform, die in über 8.000 Mitralklappenverfahren verwendet wurde, hat die Technologie eine erhebliche Reduzierung der Mitralklappeninsuffizienz und eine Verbesserung der Lebensqualität gezeigt.
Die Ergebnisse der ENCIRCLE entscheidenden Studie werden für Ende 2025 erwartet, mit einer geplanten europäischen klinischen Nachbeobachtungsstudie, die Patienten bis zu fünf Jahre lang verfolgt.
- First-to-market advantage with CE Mark approval for transfemoral transcatheter mitral valve replacement
- Proven SAPIEN platform with 8,000+ successful mitral procedures
- Only company offering both replacement and repair options for mitral and tricuspid valves in Europe
- Clinical data shows substantial reduction in mitral regurgitation
- Product not yet approved in the United States market
- Requires complex two-step surgical procedure
- to patients unsuitable for conventional surgery or TEER therapy
Insights
Edwards Lifesciences' achievement of CE Mark for its SAPIEN M3 mitral valve replacement system represents a significant breakthrough in structural heart innovation. As the world's first transfemoral transcatheter mitral valve replacement system approved in Europe, this technology fills a critical treatment gap for patients with moderate-to-severe or severe mitral regurgitation who aren't candidates for surgery or transcatheter edge-to-edge repair.
The approval strategically positions Edwards as the only company offering both replacement and repair options for mitral and tricuspid valves in Europe, creating a comprehensive portfolio that addresses diverse patient needs. This competitive advantage stems from Edwards' established SAPIEN platform, which has accumulated data from over 8,000 procedures in the mitral position.
The technological differentiation lies in the system's novel two-step approach: a docking mechanism that creates a stable landing zone by wrapping around native mitral leaflets, followed by valve placement - all delivered percutaneously through the femoral vein. This less invasive approach compared to traditional open-heart surgery could drive physician adoption and expand the addressable patient population.
While the company hasn't released specific revenue projections, mitral regurgitation represents the most common form of valvular heart disease, suggesting substantial market potential. The expected presentation of the ENCIRCLE pivotal trial results in late 2025 will provide critical data that could influence adoption rates and potential expansion to additional markets, including eventual FDA consideration.
Edwards' SAPIEN M3 Transcatheter Mitral Valve Replacement System
“Edwards’ 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations and the SAPIEN M3 system is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We were the first to gain CE Mark for a transcatheter tricuspid valve replacement system, and with the SAPIEN M3 system’s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the broad and diverse needs of these patients in Europe.”
The procedure for the SAPIEN M3 system involves two steps, delivering the dock and then the valve to completely replace the mitral valve. The dock wraps around the native mitral leaflets which pulls them and the chordae inward toward the center of the dock, bringing the papillary muscles closer together. The dock creates a stable and consistent landing zone for placing the SAPIEN M3 valve. Both the dock and the valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.
“Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,” said Dr. Michael Mullen, Barts Heart Centre, St Bartholomew’s Hospital,
Data have shown that the SAPIEN M3 system substantially reduces MR and improves quality of life. The company expects to present results from the ENCIRCLE pivotal trial, studying the SAPIEN M3 system, in late 2025. As part of Edwards’ commitment to building a body of real-world evidence, a European Post-Market Clinical Follow-up Study is planned to continue evaluation of the SAPIEN M3 system, with patients followed up to five years.
Edwards’ portfolio of transcatheter mitral and tricuspid therapies with CE Mark also includes the PASCAL Precision mitral and tricuspid valve repair system, and the EVOQUE tricuspid valve replacement system. The SAPIEN M3 system is not yet approved in
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. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, procedure 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 M3, ENCIRCLE, EVOQUE, PASCAL, PASCAL Precision, SAPIEN, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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Media Contact: Loree Bowen, 714-403-2475
Investor Contact: Mark Wilterding, 949-250-6826
Source: Edwards Lifesciences Corporation
FAQ
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