First results from the ACURATE Prime XL human feasibility study

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Device Technology

Background:

• Severe aortic stenosis poses significant risks, necessitating advanced treatment options.
• Transcatheter aortic valve replacement (TAVR) has emerged as a key therapeutic strategy.
• The ACURATE Prime XL is an advanced TAVR device designed for larger aortic annuli.

Purpose of the Study:

• To evaluate the safety and efficacy of the ACURATE Prime XL TAVR system.
• To assess device performance in patients with severe aortic stenosis and large annuli (26.5–29 mm).
• To determine the feasibility of this novel TAVR iteration in a clinical setting.

Main Methods:

• Prospective, open-label, single-arm, first-in-human feasibility study.
• Evaluation of the ACURATE Prime XL device in 13 high-risk patients.
• Primary endpoints included device success (VARC-2 criteria) and safety (30-day mortality and stroke).
• Aortic valve performance (gradient, area, paravalvular leak) assessed by an independent core laboratory.

Main Results:

• 61.5% of patients achieved the primary device success endpoint.
• No deaths or strokes were observed at 30 days post-procedure.
• Significant improvement in mean aortic valve gradient and area post-TAVR.
• No moderate or severe paravalvular leak (PVL) at 30 days; 91.7% had no/trace PVL.

Conclusions:

• The ACURATE Prime XL TAVR system demonstrated a favorable safety profile in this initial study.
• The device achieved good hemodynamic performance with minimal paravalvular leak.
• These findings support the potential of ACURATE Prime XL for treating patients with severe aortic stenosis and large aortic annuli.