Dr. Raj Makkar of Cedar-Sinai Medical Center presented data at PCR London Valves 2024. The 30-day outcomes came from the first combined dataset analysis evaluating the safety and efficacy of the Acurate prime aortic valve platform — exclusively the 29mm (XL) size in patients with a larger annulus.
Investigators evaluated a total of 102 patients with severe aortic stenosis indicated for transcatheter aortic valve replacement (TAVR). Subjects had a native annulus diameter of 26.5-29mm. The combined dataset analysis demonstrated positive outcomes with the Acurate Prime XL valve at discharge and 30 days post-procedure.
Boston Scientific reported that the analysis included data from 13 patients in its Acurate Prime XL valve human feasibility study, 50 patients in its Acurate Prime XL nested registry and 39 patients in the Acurate IDE continued access cohort for Prime XL only.
Makkar reported no deaths or strokes through 30 days. Investigators reported a rate of non-disabling stroke of 1% at discharge and an all-stroke rate of 2% at 30 days. New permanent pacemaker rate came in at 5.9% at discharge and 12.7% at 30 days. Boston Scientific also reports favorable hemodynamics, improved aortic valve area and single-digit gradient sustained through 30 days. Zero patients had moderate or greater paravalvular regurgitation at 30 days.
Investigators say the early clinical outcomes with the new Acurate platform and valve size align with results seen in other TAVR studies involving patients with extra-large annuli. Boston Scientific plans to share additional results across the entire size matrix in 2025.
Acurate Prime is Boston Scientific’s newest TAVR technology. It remains investigational in the U.S. but earned CE mark in August.
