Recently,Boston Scientific Corporation (NYSE: BSX) shared the latest clinical data on its Acurate Prime XL aortic valve system through Dr. Raj Makkar of Cedar-Sinai Medical Center at the PCR London Valves 2024 conference, highlighting the system's safety and efficacy.

The data released this time is based on the first comprehensive dataset analysis, specifically evaluating the performance of the Acurate aortic valve platform in patients with larger annuli (only 29 millimeters, or XL size). The research team included a total of 102 patients with severe aortic stenosis requiring transcatheter aortic valve replacement (TAVR), whose native annulus diameters ranged between 26.5 and 29 millimeters.

Comprehensive dataset analysis shows that the Acurate Prime XL system achieved encouraging clinical outcomes at patient discharge and 30 days post-procedure. Boston Scientific Corporation reported that the analysis integrated data from 13 patients in the Acurate Prime XL Human Feasibility Study, 50 patients in the Acurate Prime XL nested registry, and 39 patients in the dedicated Prime XL Acurate IDE Continued Access Cohort.

Dr. Makkar pointed out in the report,During the 30-day follow-up period, no deaths or stroke events occurred. Researchers also reported a non-disabling stroke rate of 1% at discharge and an all-stroke rate of 2% at 30 days. Additionally, the rate of new permanent pacemaker implantations was 5.9% at discharge and 12.7% at 30 days.

Boston Scientific Corporation also reported good hemodynamic performance, with improved aortic valve area and sustained single-digit gradients for 30 days. Notably, no patients experienced moderate or severe paravalvular regurgitation within the 30-day follow-up period.

Researchers said that the early clinical results of the Acurate platform and the new valve size are consistent with the findings of other TAVR studies involving patients with oversized valve annuli. Boston Scientific plans to release more clinical outcomes on the full sizing matrix in 2025.

Acurate Prime, as Boston Scientific Corporation's latest TAVR technology, is still in the research phase in the United States but received the CE mark in August this year. The technology features a layered design, predictable commissural alignment, and a unique top-down deployment method, aiming to deliver the predictable performance required today while meeting patients' future treatment needs.

The design features of Acurate Prime include an enhanced coronary access valve frame, aimed at providing a larger effective orifice area (EOA) and low gradient. Its design allows for the uniform distribution of radial force around the circumference, enabling faster and more controlled deployment. Additionally, its Active PVseal™ technology, with a 360° dynamic sealing skirt, helps reduce paravalvular leakage (PVL) and simplifies the device preparation process. ACURATE Prime XL, an upgraded version of the ACURATE neo2 valve, incorporates advanced Active PVseal™ technology and is equipped with an extended sealing skirt covering the full length of the stent waist, as well as radiopaque positioning markers that provide clear visual reference for precise placement. Both systems also feature an ultra-wide stable arch design to optimize coronary access.

However, the main difference between ACURATE Prime XL and ACURATE neo2 lies in its increased size. Considering that a larger size may lead to reduced radial force, ACURATE Prime XL innovatively introduces a connecting strut design, which effectively enhances the radial force of the valve, ensuring its stability and functionality in vivo.

In terms of the delivery system, ACURATE Prime XL adopts the ACURATE Prime TF XL delivery system, which has been optimized and adjusted based on the femoral (TF) delivery system of ACURATE neo2. In addition, ACURATE Prime XL is highly compatible with the 14F iSLEEVE introducer and is equipped with a brand-new distal release mechanism. This mechanism enables faster, one-time final valve release while significantly improving the valve separation effect, providing a strong guarantee for the success of the surgery.

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