MARLBOROUGH, Mass., November 27, 2022 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced top results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluating the performance of ACURATE neo2MT Aortic valve system. The results, which included a high procedural success rate of 98.4% and low mortality and paravalvular leak (PVL) rates, were presented in a late-breaking clinical trial session at PCR London Valves 2022 and published simultaneously in EuroIntervention.
In this European study, the primary safety endpoint of all-cause mortality was 0.8% at 30 days. The data also demonstrated that no patients had greater than moderate PVL, 1.9% had moderate PVL and 18.9% had mild PVL. Other notable study results include a low 6.5% rate of new pacemaker implantation 30 days post-procedure, with no incidence of disabling stroke or acute kidney injury.
“With this fundamental data set, we now have post-marketing surveillance results that validate the use of the current generation of ACURATE. neo2 valve for the management of patients with severe aortic stenosis,” said Dr. Lars Søndergaard, Professor of Cardiology, DMSc, FESC, Department of Cardiology, Rigshospitalet and co-principal investigator of the study. “The data suggests that the ring seal technology minimizes leakage around the valve – delivering greater improvement in PVL than seen with the previous generation ACURATE neo valve – while maintaining steady-state pacemaker rates in the single digits, contributing to better long-term patient outcomes. »
The prospective, single-arm ACURATE neo2 PMCF study includes 250 patients with severe aortic stenosis across 18 European centers and will assess outcomes for five years after the procedure. It also includes a primary imaging parameter to assess visually apparent thickening of prosthetic valve leaflets (HALT), a phenomenon with theoretical potential effects on valve durability or thrombotic complications. The reported HALT rate of 24.5% at 30 days after the procedure is within the range shown in previous TAVR trials with competitor devices.
“These test data confirms the success of the significant and differentiated enhancements included in the design of the ACURATE neo2 valve, from low PVL rates and first time pacemaker implantation to excellent hemodynamic performance and high procedural success and safety rates,” said Dr. Ian Meredith, Global Medical Director, 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.”
THE EXACT neo2 The aortic valve system received CE Mark in 2020 and is being evaluated in the enrolling ACURATE IDE trial in the United States and Canada.
To learn more, visit www.bostonscientific.com.eu/acurateneo2.
*In the United States, the ACURATE neo2MT The Aortic Valve System is an investigational device and is not available for sale.
** Dr. Søndergaard has not been compensated by Boston Scientific Corporation for his work on the ACURATE neo2 PMCF study or his citation in this press release.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by delivering a wide range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and log on to Twitter and Facebook.
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