BSX : Post-market Study Data Reinforce Success & Safety Of ACURATE Neo2 Aortic Valve System

(RTTNews) - Boston Scientific Corp. (BSX) said that post-market study data reinforced clinical procedural success and safety of the ACURATE neo2 Aortic Valve System.

The ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluated the performance of the ACURATE neo2TM Aortic Valve System. The findings showed a high procedural success rate of 98.4% and low rates of mortality and paravalvular leak (PVL).

In the European study, the primary safety endpoint of all-cause mortality was 0.8% at 30 days. The data also demonstrated that no patients experienced greater than moderate PVL, 1.9% experienced moderate PVL and 18.9% experienced mild PVL. Other notable findings from the study included a low 6.5% rate of new pacemaker implantation 30 days post procedure, with no incidence of disabling stroke or acute kidney injury.

The single-arm, prospective ACURATE neo2 PMCF study includes 250 patients with severe aortic stenosis from 18 European centers and will evaluate outcomes for five years following the procedure.

The ACURATE neo2 Aortic Valve System received CE Mark in 2020 and is being evaluated in the currently enrolling ACURATE IDE trial in the U.S. and Canada.