Latest Post-Marketing Study Data Reinforces ACURATE neo2™ Aortic Valve System Clinical Procedure Success and Safety

Latest Post-Marketing Study Data Reinforces ACURATE neo2™ Aortic Valve System Clinical Procedure Success and Safety

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.

ACURATE neo2™ Aortic Valve System.

ACURATE neo2™ Aortic Valve System.

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.

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*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 and log on to Twitter and Facebook.

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words such as “anticipate”, “will expect”, “plan”, “believe”, “plan”, “estimate”, “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, our clinical trials and the performance and impact of our products. If our underlying assumptions prove incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this Press release. Accordingly, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that could cause such differences include, among others: future economic, competitive, reimbursement and regulatory conditions; new product launches; demographic trends; intellectual property; dispute; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a more detailed listing and description of these material risks and uncertainties, as well as other material risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors of our most recent annual report on form. 10-K filed with the Securities and Exchange Commission, which we may update Part II, Item 1A – Risk Factors in quarterly reports on Form 10-Q that we have filed or hereafter file. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions or circumstances on which such expectations may be based, or which may affect the likelihood that actual results differ from those contained in the forward-looking statements. This cautionary statement applies to all forward-looking statements contained in this document.

Angela Mineo
Media Relations
(763) 955-8325 (office)

Lauren Tengler
Investor Relations
(508) 683-4479

Boston Scientific Corporation (PRNewsFoto/Boston Scientific Corporation) (PRNewsFoto/Boston Scientific Corporation)

Boston Scientific Corporation (PRNewsFoto/Boston Scientific Corporation) (PRNewsFoto/Boston Scientific Corporation)



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