Boston Scientific Obtains CE Mark for ACURATE Prime™ Aortic Valve System
Boston Scientific (NYSE: BSX) has obtained CE mark for its ACURATE Prime™ Aortic Valve System, a new transcatheter aortic valve replacement (TAVR) technology. This system expands treatment options for patients with larger anatomy and is designed for low, intermediate, and high-risk patients with severe aortic stenosis. Key features include:
- An enhanced frame for stable fit
- Redesigned deployment mechanism for accurate positioning
- Expanded treatment range (aortic annulus diameters 20.5-29 mm)
- Low pacemaker and paravalvular leak rates
- Strong hemodynamic performance
- Unrestricted coronary access for future procedures
The ACURATE Prime system will be launched in Europe in the coming weeks, building on the success of the ACURATE platform, which has been implanted in nearly 80,000 patients globally.
Boston Scientific (NYSE: BSX) ha ottenuto il marchio CE per il suo ACURATE Prime™ Aortic Valve System, una nuova tecnologia di sostituzione della valvola aortica transcatetere (TAVR). Questo sistema amplia le opzioni di trattamento per i pazienti con anatomia più grande ed è progettato per pazienti a basso, medio e alto rischio con stenosi aortica severa. Le caratteristiche chiave includono:
- Un telaio migliorato per una vestibilità stabile
- Meccanismo di distribuzione riprogettato per un posizionamento accurato
- Raggio di trattamento ampliato (diametri dell'anello aortico 20,5-29 mm)
- Bassi tassi di pacemaker e perdite paravalvolari
- Elevate prestazioni emodinamiche
- Accesso coronarico illimitato per future procedure
Il sistema ACURATE Prime sarà lanciato in Europa nelle prossime settimane, costruendo sul successo della piattaforma ACURATE, che è stata impiantata in quasi 80.000 pazienti a livello globale.
Boston Scientific (NYSE: BSX) ha obtenido la marca CE para su ACURATE Prime™ Aortic Valve System, una nueva tecnología de reemplazo de válvula aórtica transcatéter (TAVR). Este sistema expande las opciones de tratamiento para pacientes con anatomía más grande y está diseñado para pacientes de bajo, intermedio y alto riesgo con estenosis aórtica severa. Las características clave incluyen:
- Un marco mejorado para un ajuste estable
- Mecanismo de despliegue rediseñado para un posicionamiento preciso
- Rango de tratamiento ampliado (diámetros de anillo aórtico de 20.5 a 29 mm)
- Bajas tasas de marcapasos y fugas paravalvulares
- Fuerte rendimiento hemodinámico
- Acceso coronario sin restricciones para futuros procedimientos
El sistema ACURATE Prime se lanzará en Europa en las próximas semanas, aprovechando el éxito de la plataforma ACURATE, que se ha implantado en casi 80,000 pacientes en todo el mundo.
보스턴 사이언티픽(Boston Scientific, NYSE: BSX)은 새로운 경피적 대동맥 판막 대체(TAVR) 기술인 ACURATE Prime™ 대동맥 판막 시스템에 대해 CE 인증을 획득했습니다. 이 시스템은 더 큰 해부학적 구조를 가진 환자들을 위한 치료 옵션을 확장하며, 중등도 이상의 심각한 대동맥 협착증을 가진 저위험, 중위험, 고위험 환자들을 위해 설계되었습니다. 주요 특징은 다음과 같습니다:
- 안정적인 장착을 위한 향상된 프레임
- 정확한 위치 배치를 위한 재설계된 배치 메커니즘
- 확대된 치료 범위(대동맥 링 직경 20.5-29 mm)
- 낮은 박동조율기 및 판막주위 누출 비율
- 강력한 혈역학적 성능
- 향후 절차를 위한 무제한 관상 동맥 접근
ACURATE Prime 시스템은 앞으로 몇 주 내에 유럽에서 출시될 예정이며, 이는 세계적으로 거의 80,000명의 환자에게 이식된 ACURATE 플랫폼의 성공을 기반으로 하고 있습니다.
Boston Scientific (NYSE: BSX) a obtenu le marquage CE pour son ACURATE Prime™ Aortic Valve System, une nouvelle technologie de remplacement de la valve aortique transcatheter (TAVR). Ce système élargit les options de traitement pour les patients ayant une anatomie plus grande et est conçu pour les patients à faible, intermédiaire et haut risque souffrant d'une sténose aortique sévère. Les caractéristiques clés comprennent :
- Un cadre amélioré pour un ajustement stable
- Un mécanisme de déploiement redessiné pour un positionnement précis
- Une plage de traitement élargie (diamètres de l’anneau aortique de 20,5 à 29 mm)
- Faibles taux de stimulateur cardiaque et de fuites paravalvulaires
- Excellentes performances hémodynamiques
- Accès coronarien illimité pour les futures procédures
Le système ACURATE Prime sera lancé en Europe dans les semaines à venir, s'appuyant sur le succès de la plateforme ACURATE, qui a été implantée chez près de 80 000 patients dans le monde.
Boston Scientific (NYSE: BSX) hat die CE-Kennzeichnung für sein ACURATE Prime™ Aortic Valve System erhalten, eine neue Technologie für den transkatheter Aortenklappenersatz (TAVR). Dieses System erweitert die Behandlungsmöglichkeiten für Patienten mit größerer Anatomie und wurde für Patienten mit niedrigem, mittlerem und hohem Risiko mit schwerer Aortenstenose entwickelt. Zu den Hauptmerkmalen gehören:
- Ein verbessertes Gestell für einen stabilen Sitz
- Überarbeitetes Entnahmeverfahren für eine präzise Positionierung
- Erweiterter Behandlungsbereich (Durchmesser des aortalen Annulus 20,5-29 mm)
- Niedrige Raten für Schrittmacher und paravalvuläre Leckagen
- Starke hämodynamische Leistung
- Unbeschränkter Zugang zu den Koronararterien für zukünftige Eingriffe
Das ACURATE Prime-System wird in den kommenden Wochen in Europa eingeführt und baut auf dem Erfolg der ACURATE-Plattform auf, die weltweit bei fast 80.000 Patienten implantiert wurde.
- Obtained CE mark for ACURATE Prime™ Aortic Valve System
- Expands treatment range to patients with larger anatomy
- Designed for low, intermediate, and high-risk patients with severe aortic stenosis
- Enhanced frame and redesigned deployment mechanism for improved performance
- Low pacemaker and paravalvular leak rates reported
- Strong hemodynamic performance demonstrated
- Unrestricted coronary access for future procedures
- None.
Insights
The CE mark approval for Boston Scientific's ACURATE Prime™ Aortic Valve System is a significant development in the TAVR market. This new system expands treatment options for patients with larger anatomies, potentially increasing Boston Scientific's market share. Key improvements include:
- Enhanced frame design for better stability
- Redesigned deployment mechanism for accurate positioning
- Expanded treatment range (20.5-29 mm annulus diameters)
These features address critical challenges in TAVR procedures, potentially leading to better patient outcomes and increased physician adoption. The system's ability to maintain low pacemaker and paravalvular leak rates, while ensuring unrestricted coronary access, positions it competitively in the market.
From a clinical perspective, the ACURATE Prime™ system offers several advantages. The supra-annular design and enhanced frame could lead to improved hemodynamics and valve longevity. The system's ability to treat a wider range of patient anatomies is particularly noteworthy, as it addresses a significant limitation in current TAVR options. The reported low pacemaker and paravalvular leak rates are important for reducing post-procedure complications. However, long-term data will be necessary to fully assess its performance against established alternatives. The system's design for future coronary access is forward-thinking, considering the younger patient population now receiving TAVR.
This CE mark approval strengthens Boston Scientific's position in the competitive TAVR market. With an expanded patient pool and enhanced features, the company could see increased adoption rates in Europe. The TAVR market is projected to grow at a CAGR of
The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes force across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.
"The introduction of the ACURATE Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures."
The ACURATE Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates,1,2 strong hemodynamic performance,1 as well as unrestricted coronary access for future procedures.
"We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients."
The company will initiate the launch of the ACURATE Prime valve system in
*In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
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1 Rück A, Kim WK, Abdel-Wahab M, et al. The Early neo2 Registry: Transcatheter Aortic Valve Implantation with ACURATE neo2 in a European Population. J Am Heart Assoc. 2023 Aug;12(15):e029464.
2 Kim WK, Tamburino C, Möllmann H, et al. Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study. EuroIntervention. 2023 May 12;19(1):83-92.
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SOURCE Boston Scientific Corporation
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