ACURATE neo2™ Aortic Valve System Data Presented at Late-Breaking Clinical Trial Session at TCT 2024
Boston Scientific (NYSE: BSX) announced results from the ACURATE IDE clinical trial evaluating their ACURATE neo2™ Aortic Valve System for treating severe aortic stenosis. The trial's primary endpoint showed a 16.16% composite rate of all-cause mortality, stroke, or rehospitalization at one year in the ACURATE neo2 arm versus 9.53% in the control arm, failing to meet non-inferiority criteria. A post-hoc analysis revealed approximately 20% of valves were under-expanded, with data showing similar outcomes between properly expanded ACURATE neo2 valves and the control group. The company continues working with the FDA on regulatory approval strategy.
Boston Scientific (NYSE: BSX) ha annunciato i risultati dello studio clinico ACURATE IDE che valuta il loro sistema di valvola aortica ACURATE neo2™ per il trattamento della stenosi aortica severa. L'endpoint primario dello studio ha mostrato un tasso composito del 16.16% di mortalità per tutte le cause, ictus o ri-ospedalizzazione a un anno nel braccio ACURATE neo2 rispetto al 9.53% del braccio di controllo, non riuscendo a soddisfare i criteri di non inferiorità. Un'analisi post-hoc ha rivelato che circa il 20% delle valvole erano sottodimensionate, con dati che mostrano esiti simili tra le valvole ACURATE neo2 correttamente espanse e il gruppo di controllo. L'azienda continua a lavorare con la FDA sulla strategia di approvazione regolatoria.
Boston Scientific (NYSE: BSX) anunció los resultados del ensayo clínico ACURATE IDE que evalúa su sistema de válvula aórtica ACURATE neo2™ para el tratamiento de la estenosis aórtica severa. El objetivo primario del ensayo mostró una tasa compuesta del 16.16% de mortalidad por todas las causas, accidente cerebrovascular o rehospitalización a un año en el grupo ACURATE neo2 frente al 9.53% en el grupo de control, sin cumplir con los criterios de no inferioridad. Un análisis post-hoc reveló que aproximadamente el 20% de las válvulas estaban subexpandidas, con datos que muestran resultados similares entre las válvulas ACURATE neo2 correctamente expandidas y el grupo de control. La compañía sigue trabajando con la FDA en la estrategia de aprobación regulatoria.
보스턴 사이언티픽(Boston Scientific, NYSE: BSX)은 심한 대동맥 협착증 치료를 위한 ACURATE neo2™ 대동맥 판막 시스템을 평가하는 ACURATE IDE 임상 시험 결과를 발표했습니다. 시험의 주요 종료 지표는 ACURATE neo2 그룹에서 1년 이내에 모든 원인에 의한 사망, 뇌졸중 또는 재입원에 대해 16.16%의 복합 비율을 보였으며, 대조군에서는 9.53%로 나타났습니다. 이는 비열등성 기준을 충족하지 못한 결과입니다. 사후 분석 결과 약 20%의 판막이 확장이 부족한 것으로 나타났으며, 적절하게 확장된 ACURATE neo2 판막과 대조군 사이에는 유사한 결과가 나타났습니다. 회사는 FDA와 규제 승인 전략을 계속 작업하고 있습니다.
Boston Scientific (NYSE: BSX) a annoncé les résultats de l'essai clinique ACURATE IDE évaluant leur système de valve aortique ACURATE neo2™ pour le traitement de la sténose aortique sévère. L'objectif principal de l'essai a montré un taux composite de 16,16% de mortalité toutes causes confondues, d'accident vasculaire cérébral ou de réhospitalisation à un an dans le bras ACURATE neo2 contre 9,53% dans le bras de contrôle, ne répondant pas aux critères de non-infériorité. Une analyse post-hoc a révélé qu'environ 20% des valves étaient sous-expansées, avec des données montrant des résultats similaires entre les valves ACURATE neo2 correctement expansées et le groupe de contrôle. L'entreprise continue à travailler avec la FDA sur la stratégie d'approbation réglementaire.
Boston Scientific (NYSE: BSX) hat die Ergebnisse der klinischen Studie ACURATE IDE veröffentlicht, die ihr ACURATE neo2™ Aortenklappensystem zur Behandlung der schweren Aortenstenose bewertet. Der primäre Endpunkt der Studie zeigte eine 16,16% zusammengesetzte Rate an Gesamtmortalität, Schlaganfall oder Wiederaufnahme ins Krankenhaus nach einem Jahr in der ACURATE neo2-Gruppe im Vergleich zu 9,53% in der Kontrollgruppe, wobei die Kriterien für Nichtunterlegenheit nicht erfüllt wurden. Eine Post-hoc-Analyse ergab, dass etwa 20% der Klappen unzureichend expandiert waren, und die Daten zeigten ähnliche Ergebnisse zwischen korrekt expandierten ACURATE neo2-Klappen und der Kontrollgruppe. Das Unternehmen arbeitet weiterhin mit der FDA an der Strategie zur regulatorischen Zulassung.
- Post-hoc analysis showed similar outcomes between properly expanded ACURATE neo2 valves and control group
- Device already has CE mark approval in Europe
- Failed to meet primary endpoint non-inferiority criteria (16.16% vs 9.53% composite rate)
- 20% of valves were under-expanded in the trial
- Regulatory approval in US still pending
Insights
The ACURATE IDE trial results reveal significant challenges for Boston Scientific's TAVR ambitions. The 16.16% composite rate for adverse events in the ACURATE neo2 arm versus 9.53% in the control arm, failing to meet non-inferiority criteria, represents a considerable setback for market expansion. The post-hoc analysis identifying 20% of valves being under-expanded suggests procedural optimization issues rather than inherent device limitations.
The findings will likely delay U.S. market entry and require additional clinical validation, impacting BSX's competitive position against established TAVR leaders Edwards Lifesciences and Medtronic. While the European market presence provides some revenue stream through CE-marked versions, the missed primary endpoint could affect physician adoption rates and market share growth in existing markets.
The TAVR market, valued at over
However, the identification of procedural optimization opportunities provides a pathway for improvement. BSX's commitment to additional studies with refined techniques demonstrates a strategic approach to addressing the challenges, though this will require substantial investment and time. The European presence maintains revenue potential while U.S. approval efforts continue.
This randomized trial evaluated the ACURATE neo2 valve, the company's second-generation transcatheter aortic valve replacement (TAVR) technology, versus a pre-defined control valve, either the commercially available SAPIEN™ valve or the Evolut™ transcatheter aortic valve system, selected at the discretion of the implanting physician. The composite rate of all-cause mortality, stroke or rehospitalization at one year was
"This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and co-principal investigator of the ACURATE IDE trial. "These data add to the breadth of clinical knowledge of the ACURATE valve platform and provide compelling insights on the importance of procedural optimization that will be beneficial for TAVR moving forward."
Also presented in the late-breaking session were data from a post-hoc analysis to identify and evaluate expanded and under-expanded ACURATE neo2 valve frames within the ACURATE IDE trial. The company performed a review of key procedural factors, including pre- and post-dilation, which helps to prepare for, enable and confirm proper valve expansion during the procedure. Following this review, an assessment of implant quality for the ACURATE neo2 valve was initiated and highlighted that approximately
"The data presented today give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "We believe the findings from the ACURATE IDE post-hoc analysis and implementation of steps to mitigate valve under-expansion may improve outcomes for the ACURATE valve and have important implications on other commercially available TAVR valves, and we look forward to studying these improved techniques in future trials of the device."
Boston Scientific continues to work closely with the
More information on the ACURATE IDE trial is available here.
*In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the
**Dr. Michael Reardon is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
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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