ACURATE neo2™ Aortic Valve System Data Presented at Late-Breaking Clinical Trial Session at TCT 2024

Rhea-AI Summary

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.

Positive

• Post-hoc analysis showed similar outcomes between properly expanded ACURATE neo2 valves and control group
• Device already has CE mark approval in Europe

Negative

• 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

MARLBOROUGH, Mass. and WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the results of the primary endpoint of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2™ Aortic Valve System in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. The data were presented as a late-breaking clinical trial at Transcatheter Cardiovascular Therapeutics^® (TCT^®) 2024, the annual scientific symposium of the Cardiovascular Research Foundation^® (CRF^®).

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 16.16% in the ACURATE neo2 arm and 9.53% in the control arm, not meeting the prespecified criterion for non-inferiority (posterior probability for non-inferiority was 77.9%, which is lower than the non-inferiority test threshold of 97.5%).

"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 20% of the valves were under-expanded. Data from the assessment also demonstrated that the rate for death, stroke or rehospitalization at one year was similar between the ACURATE neo2 expanded group and the control group.

"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 U.S. Food and Drug Administration on the regulatory strategy for approval of the ACURATE valve platform in the U.S.

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 USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale.

**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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SOURCE Boston Scientific Corporation

FAQ

What were the ACURATE IDE trial results for Boston Scientific's (BSX) ACURATE neo2 valve?

The trial showed a 16.16% composite rate of mortality, stroke, or rehospitalization at one year for ACURATE neo2 versus 9.53% in the control arm, failing to meet non-inferiority criteria.

What percentage of ACURATE neo2 valves were under-expanded in the BSX clinical trial?

According to the post-hoc analysis, approximately 20% of the ACURATE neo2 valves were under-expanded during the trial.

Is Boston Scientific's (BSX) ACURATE neo2 valve approved in the US?

No, the ACURATE neo2 valve is currently an investigational device in the US and is restricted to investigational use only, pending FDA approval.