Data backs Boston Scientific Acurate neo2 aortic valve - Mass Device

Acurate Neo2 [Image from Boston Scientific]

Boston Scientific (NYSE:BSX) announced affirmative results from its post-market objective follow-up survey for the Acurate neo2 aortic valve system.

Marlborough, Massachusetts-based Boston Scientific’s findings included a precocious procedural occurrence complaint of 98.4%. The survey observed debased rates of mortality and paravalvular leak (PVL).

Findings, presented astatine PCR London Valves 2022, simultaneously published successful EuroIntervention, according to a quality release.

The European survey included a superior information endpoint of all-cause mortality acceptable astatine 0.8% astatine 30 days. Data besides demonstrated that nary patients experienced greater than mean PVL. It recovered that 1.9% experienced mean PVL and 18.9% experienced mild PVL. Other findings included a debased 6.5% complaint of caller pacemaker implantation astatine 30 days post-procedure. Boston Scientific’s instrumentality demonstrated nary incidence of disabling changeable oregon acute kidney injury.

“With this foundational information set, we present person post-market surveillance results that validate the usage of the current-generation Acurate neo2 valve for the absorption of patients with terrible aortic stenosis,” said Dr. Lars Søndergaard, prof of cardiology, Department of Cardiology, Rigshospitalet and survey co-principal investigator. “The information suggest that the annular sealing exertion minimizes leakage astir the valve – providing greater betterment successful PVL than observed with the prior-generation Acurate neo valve – each portion maintaining single-digit imperishable pacemaker rates, which contributes to amended semipermanent diligent outcomes.”

About the study

The single-arm, prospective survey includes 250 patients with terrible aortic stenosis crossed 18 European centers. The survey evaluates outcomes for 5 years post-procedure. It besides includes a superior imaging endpoint to measure the visually evident thickening of the prosthetic valve leaflets (HALT).

Boston Scientific said the reported halt complaint astatine 30 days post-procedure came successful astatine 24.5%. That falls wrong the scope presented successful erstwhile TAVR trials with competitory devices.

Acurate neo2 received CE people support successful 2020. Currently, Boston Scientific is enrolling successful an investigational instrumentality exemption proceedings successful the U.S. and Canada.

The latest information follows aggregate presentations this twelvemonth highlighting occurrence with Acurate neo2. In June, study results demonstrated affirmative hemodynamic show and objective outcomes. In May, Boston Scientific presented a survey evaluating a caller implant technique. It demonstrated that commissural alignment tin beryllium achieved safely, efficaciously and quickly.

“These proceedings information corroborate the occurrence of meaningful and differentiated enhancements included successful the plan of the Acurate neo2 valve, from debased rates of PVL and first-time pacemaker implantation to fantabulous hemodynamic show and precocious rates of procedural occurrence and safety,” said Dr. Ian Meredith, planetary CMO, Boston Scientific. “We look guardant to reviewing longer-term results from this proceedings and bringing this differentiated TAVR exertion to much patients and their physicians.”