Dr. Andreas Rück, head of the transcatheter aortic valve implantation (TAVI) program at Karolinska University Hospital in Stockholm, Sweden, presented key findings from the Early ACURATE Prime Registry at EuroPCR in Paris. It marks the first large, real-world clinical data on the company’s latest TAVI device following its European approval and launch last year.
Rück shared findings from 517 patients across 12 European sites. Outcomes included high rates of technical success (98.6%) and 30-day device success (96.4%). Overall new permanent pacemaker (PPI) rates landed in the single digits at 9.8%.
Boston Scientific reported a 30-day post-implant aortic valve area (AVA) of 2.6cm2. The study also saw favorable core-lab adjudicated hemodynamic results at 30 days. That included a low severe or moderate paravalvular leakage (PVL) rate of 1.2% and an aortic mean gradient of 7.2 mmHg.
Marlborough, Massachusetts-based Boston Scientific designed Acurate Prime to build upon the clinical performance of the Acurate neo2 platform. It has additional valve sizes to expand the treatment range to patients with a larger anatomy.
The new TAVR system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate, and high-risk patients with severe aortic stenosis. Acurate Prime is self-expanding and has a supra-annular design. Its enhanced frame equalizes force across the valve for a stable fit against the native, diseased valve.
Acurate Prime remains investigational in the U.S.
