Boston Scientific (NYSE:BSX) has released data underscoring the safety and effectiveness of its Acurate Prime aortic valve system.
At the 2024 PCR London Valves conference, Dr. Raj Makkar from Cedar-Sinai Medical Center shared insights. The 30-day results were derived from the first comprehensive analysis focusing on evaluating the safety and efficacy of the Acurate prime aortic valve platform, particularly the 29mm (XL) size for patients with larger annuli.
Researchers assessed a group of 102 patients suffering from severe aortic stenosis and deemed suitable for transcatheter aortic valve replacement (TAVR). Those studied had a native annulus diameter ranging between 26.5-29mm. The combined data analysis showcased favorable outcomes for the Acurate Prime XL valve at both discharge and 30 days post-operation.
Boston Scientific conveyed that this analysis involved data from 13 subjects in their Acurate Prime XL valve human feasibility study, 50 subjects in their Acurate Prime XL nested registry, and 39 subjects in the Acurate IDE continued access cohort solely for Prime XL.
Dr. Makkar reported an absence of fatalities or strokes within the initial 30 days. The analysis noted a non-disabling stroke rate of 1% upon discharge and an all-stroke rate of 2% after 30 days. The necessity for new permanent pacemakers registered at 5.9% at discharge and rose to 12.7% after 30 days. Additionally, Boston Scientific cited favorable hemodynamic performance, enhanced aortic valve areas, and sustained single-digit gradients throughout this period. Impressively, all patients were free from moderate or greater paravalvular regurgitation by day 30.
Researchers indicate that the initial clinical outcomes with the newly developed Acurate platform and valve dimensions align with findings from other TAVR studies on patients having extra-large annuli. Boston Scientific is set to disclose more comprehensive results covering all size variations in 2025.
The Acurate Prime represents Boston Scientific’s latest advance in TAVR technology. While it remains investigational in the U.S., it received CE Mark authorization in August.