Boston Scientific has reported the initial data from the study of the ACURATE neo2 Aortic Valve System, which supports its clinical procedural success and safety.
The findings from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study included a 98.4% high procedural success rate along with low mortality and paravalvular leak (PVL) rates.
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In the European single-arm, prospective ACURATE neo2 PMCF study of the system, 0.8% was the primary safety endpoint of all-cause mortality at 30 days.
Additionally, the findings demonstrated that no subjects experienced greater than moderate PVL, with 1.9% and 18.9% experiencing moderate and mild PVL rates, respectively.
A low 6.5% rate of new pacemaker implantation 30 days after a procedure was another observation from the study, with no incidence of acute kidney injury or disabling stroke reported.
The study includes 250 severe aortic stenosis patients from 18 centres in Europe and will assess the outcomes for five years after procedures.
A primary imaging endpoint, also included in the study, will evaluate the visually apparent thickening of the prosthetic valve leaflets (HALT).
Boston Scientific global chief medical officer Dr Ian Meredith said: “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.
“We look forward to reviewing longer-term results from this trial and bringing this differentiated transcatheter aortic valve replacement (TAVR) technology to more patients and their physicians.”
In 2020, the ACURATE neo2 Aortic Valve System secured CE Mark. It is being assessed in the US and Canada, where patients are currently being enrolled, in the ACURATE IDE trial.
In September, Boston Scientific reported data from the PROTECTED TAVR clinical trial of the SENTINEL Cerebral Protection System.
