US-based biomedical company Boston Scientific has unveiled positive results from the post-market clinical follow-up (PMCF) study of its ACURATE neo2 aortic valve system.

The ACURATE neo2 PMCF study enrolled 250 patients with severe aortic stenosis, across 18 European centres, and will be evaluated for five years following the procedure.

Results from the European study showed a high procedural success rate of 98.4% and low rates of mortality and paravalvular leak (PVL).

The data showed that no patients experienced greater than moderate PVL, with all-cause mortality of 0.8% at 30 days, which is the primary safety endpoint.

In addition, the data also showed a low (6.5%) rate of new pacemaker implantation 30 days post procedure, with no incidence of disabling stroke or acute kidney injury.

In addition, the study also includes a primary imaging endpoint to assess the visually apparent thickening of the prosthetic valve leaflets (HALT).

The study co-principal investigator Lars Søndergaard said: “With this foundational data set, we now have post-market surveillance results that validate the use of the current-generation ACURATE neo2 valve for the management of patients with severe aortic stenosis.

“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.”

The ACURATE neo2 aortic valve system is a next-generation transcatheter aortic valve implantation (TAVI) technology that has received CE Mark in 2020.

It is integrated with multiple features to enhance the clinical performance over the original ACURATE neo platform.

The ACURATE neo2 valve system is designed for the restoration of function and normal blood flow through a severely narrowed aortic valve.

Boston Scientific global chief medical officer 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 TAVR technology to more patients and their physicians.”

In September 2020, Boston Scientific has commenced a controlled release of the ACURATE neo2 aortic valve system in Europe.