Marlborough, Massachusetts-based Boston Scientific’s findings included a high procedural success rate of 98.4% for the TAVR system. In addition, the study observed low rates of mortality and paravalvular leak (PVL).
Findings, presented at PCR London Valves 2022, simultaneously published in EuroIntervention, according to a news release.
The European study included a primary safety endpoint of all-cause mortality set at 0.8% at 30 days. Data also demonstrated that no patients experienced greater than moderate PVL. It found that 1.9% experienced moderate PVL, and 18.9% experienced mild PVL. Other findings included a low 6.5% rate of new pacemaker implantation at 30 days post-procedure. Boston Scientific’s device demonstrated no disabling stroke or acute kidney injury incidence.
“With this foundational data set, we now have post-market surveillance results that validate the use of the current-generation Acurate neo2 valve for the management of patients with severe aortic stenosis,” said Dr. Lars Søndergaard, professor of cardiology, Department of Cardiology, Rigshospitalet and study co-principal investigator. “The data suggest that the annular sealing technology minimizes leakage around the valve – providing greater improvement in PVL than observed with the prior-generation Acurate neo valve – all while maintaining single-digit permanent pacemaker rates, which contributes to better long-term patient outcomes.”
About the study
The single-arm, prospective study includes 250 patients with severe aortic stenosis across 18 European centers. The study evaluates outcomes for five years post-procedure. Also, it includes a primary imaging endpoint to assess the visually apparent thickening of the prosthetic valve leaflets (HALT).
Boston Scientific said the reported halt rate at 30 days post-procedure came in at 24.5%. That falls within the range presented in previous TAVR trials with competitive devices.
Acurate neo2 received CE mark approval in 2020. Currently, Boston Scientific is enrolling in an investigational device exemption trial in the U.S. and Canada.
The latest data follows multiple presentations this year highlighting success with Acurate neo2. In June, study results demonstrated positive hemodynamic performance and clinical outcomes. In May, Boston Scientific presented a study evaluating a novel implant technique. It showed that commissural alignment could be achieved safely, effectively and quickly.
“These trial data confirm the success of meaningful and differentiated enhancements included in the design of the Acurate neo2 valve, from low rates of PVL and first-time pacemaker implantation to excellent hemodynamic performance and high rates of procedural success and safety,” said Dr. Ian Meredith, global CMO, Boston Scientific. “We look forward to reviewing longer-term results from this trial and bringing this differentiated TAVR technology to more patients and their physicians.”