Veryan’s BioMimics 3D Stent Evaluated in Longer Lesions at 3 Years in Analysis From MIMICS-3D EU Registry

November 3, 2022—A post hoc subgroup analysis of the prospective, single-arm, multicenter MIMICS-3D EU registry investigated the 3-year performance of the BioMimics 3D three-dimensional (3D) vascular stent system (Veryan Medical Ltd., an Otsuka Medical Devices company) in patients with long lesion (LL) lengths (140-190 mm) and very long lesion (VLL) lengths (> 190 mm).

The BioMimics 3D device is a nitinol stent incorporating a 3D helical centerline, which is designed to provide biomechanical stability, promote swirling blood flow, and elevate wall shear stress in the stented segment.

The findings were presented by Michael Lichtenberg, MD, during the first of three Late-Breaking Clinical Trials sessions at the VIVA22 conference, hosted by The VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, the MIMICS-3D registry enrolled 507 patients at 23 European sites.

The LL and VLL cohorts were composed of 165 (33%) patients. There were 46 patients in the LL subgroup (mean lesion length, 160.2 ± 22.6 mm; 33% diabetes; 25% severe bilateral wall calcification; 58% occlusion). There were 119 patients in the VLL subgroup (mean lesion length, 269 ± 61 mm; diabetes, 40%; severe bilateral wall calcification, 38%; occlusion, 92%).

Dr. Lichtenberg reported that the primary safety outcome of major adverse events was 100% for the LL subgroup and 97% for the VLL subgroup.

The primary efficacy endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) determined by Kaplan-Maier estimate.

• In the LL subgroup, freedom from CD-TLR was 85% at 12 months and 78% at 36 months.
• In the VLL subgroup, freedom from CD-TLR was 82% at 12 months and 70% at 36 months.

The Kaplan-Meier estimate of primary patency was 85% and 75% at 12 and 36 months, respectively, for the LL subgroup. In the VLL subgroup, it was 78% and 61% at 12 and 36 months, respectively. Investigator-reported fractures through 36 months were low for both groups (0% for LL and 0.8% for VLL).

The study concluded that these results support 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 contributes to a 36-month CD-TLR rate comparable to those of drug-based devices, even in long and very long lesions, with minimal fracture risk, noted the VIVA Foundation press release.