Analysis of MIMICS-3D EU Registry Studies TASC D Lesions Treated With Veryan’s BioMimics 3D Stent

November 1, 2023—A post hoc subgroup analysis of the prospective, single-arm, multicenter MIMICS-3D EU registry evaluated the BioMimics 3D nitinol stent (Veryan Medical) in the treatment of patients with TASC-D lesions. The device features a three-dimensional (3D) helical centerline that is designed to provide biomechanical compatibility, promote swirling blood flow, and beneficially elevates wall shear stress in the stented segment.

Robert Beasley, MD, presented the findings from the analysis during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

The VIVA press release noted that patients with long-segment femoropopliteal peripheral artery disease (> 200 mm) are excluded from nearly all device trials. Traditional straight stents have demonstrated low primary patency in TASC D lesions, with one meta-analysis reporting patency at 1, 2, and 3 years to be 55%, 41%, and 35%, respectively, and only limited 2-year data are available for drug-eluting stents.

As summarized in the press release, the MIMICS-3D EU registry enrolled 507 patients at 23 sites. In the overall intention-to-treat population, the Kaplan-Meier (KM) estimates of freedom from CD-TLR at 1 and 3 years were 89% and 78%, respectively. KM estimates of freedom from loss of primary stent patency (peak systolic velocity ratio > 2.4) at 1 and 3 years were 87% and 70%, respectively.

There were 107 patients who presented with TASC D lesions, with a mean lesion length of 273 ± 60 mm, 41% diabetes, 38% severe bilateral wall calcification, and 94% occlusion.

The primary safety outcome of freedom from major adverse events was 98%, and the primary efficacy endpoint demonstrated KM estimates for freedom from clinically driven target lesion revascularization (CD-TLR) of 83% at 12 months and 71% at 36 months.

The KM estimates of primary patency were 79% at 12 months and 60% at 36 months. The stent fracture rate at 36 months was 1.9% (2/107).

The subgroup analysis on more complex TASC-D lesions from the MIMICS-3D EU registry supports the hypothesis that imparting a nonplanar curvature nitinol stent design to the femoropopliteal artery to promote swirling blood flow and increase wall shear stress is beneficial and results in 36-month CD-TLR, primary patency, and clinical outcomes that are superior to other treatment options, concluded the presentation at VIVA.