Boston Scientific’s Acurate Neo2 Aortic Valve System Evaluated in European Postmarket Study

November 27, 2022—Boston Scientific Corporation announced the first results from the Acurate Neo2 postmarket clinical follow-up (PMCF) study evaluating the performance of the company’s Acurate Neo2 aortic valve system. The company stated that the results included a high procedural success rate of 98.4% and low rates of mortality and paravalvular leak (PVL).

The Acurate Neo2 PMCF findings were presented during a late-breaking clinical trial session at the PCR London Valves 2022 course held November 27-29 in London, United Kingdom. The study was published simultaneously by Won-Keun Kim, MD, et al online in EuroIntervention.

According to the company, the single-arm, prospective study is composed of 250 patients with severe aortic stenosis at 18 European centers. Outcomes will be evaluated for 5 years after the procedure.

As summarized in Boston Scientific’s press release, the primary safety endpoint of all-cause mortality was 0.8% at 30 days. No patients experienced greater-than-moderate PVL, 1.9% experienced moderate PVL, and 18.9% experienced mild PVL. The rate of new pacemaker implantation was 6.5% at 30-days postprocedure. There was no incidence of disabling stroke or acute kidney injury.

Additionally, the findings included a primary imaging endpoint to assess the visually apparent hypoattenuated leaflet thickening (HALT), a phenomenon with theoretical potential effects on valve durability or thrombotic complications. The reported HALT rate of 24.5% at 30-days postprocedure is within the range presented in previous transcatheter aortic valve replacement (TAVR) trials with competitive devices, noted the company.

Professor of Cardiology Lars Søndergaard, MD, of the Department of Cardiology at Rigshospitalet in Copenhagen, Demark, is the Acurate Neo2 PMCF study's coprincipal investigator.

“With this foundational data set, we now have postmarket surveillance results that validate the use of the current-generation Acurate Neo2 valve for the management of patients with severe aortic stenosis,” commented Prof. Søndergaard in the company’s press release. “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.”

In September 2020, Boston Scientific announced the initial controlled launch in Europe of the Acurate Neo2, which received CE Mark approval in April 2020.

The Acurate Neo2 is being evaluated in the United States and Canada in the currently enrolling ACURATE IDE investigation device exemption trial. The Acurate Neo2 is an investigational device in the United States and is not available for sale, advised the company.