Veryan’s BioMimics 3D Shows Similar 2-Year Patency in Treatment of Claudicants and CLTI Patients

October 6, 2021—The VIVA Foundation announced that the BioMimics 3D nitinol stent (Veryan Medical), which features a three-dimensional (3D) helical centerline, was evaluated in the MIMICS-3D European registry to treat patients with longer, more complex lesions than previously studied.

According to VIVA, BioMimics 3D is designed to provide optimal radial support, flexibility, durability, and delivery accuracy for femoropopliteal intervention. The 3D helical centerline provides biomechanical compatibility and swirling blood flow to elevate wall shear stress to limit intimal hyperplasia.

Sahil A. Parikh, MD, presented the 2-year data from the MIMICS-3D study during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

The VIVA announcement stated that the MIMICS-3D registry enrolled 507 patients treated with BioMimics 3D at 23 sites: 76% were claudicants (Rutherford class 1-3) and 24% had chronic limb-threatening ischemia (CLTI; Rutherford class 4-6).

Of the claudicant patients, 34% had diabetes, 7% had renal insufficiency, mean lesion length was 126.3 ± 92.9 mm, and 54% of lesions were occluded. Of the CLTI patients, 47% had diabetes, 13% had renal insufficiency, mean lesion length was 130.2 ± 92.7 mm, and 64% of lesions were occluded.

An independent clinical events committee adjudicated major adverse events (MAEs), including death and potential device-related events.

At VIVA, Dr. Parikh reported the following:

• The primary safety endpoint, a composite of freedom from MAE comprising death, major index limb amputation, or clinically driven target lesion revascularization (CD-TLR) through 30 days, was 99% for claudicants and 97% for CLTI patients.
• The primary outcome measure for effectiveness (freedom from CD-TLR through 12 months) at 1 and 2 years was 92% and 85% for claudicants and 85% and 77% for CLTI.
• Kaplan-Meier freedom from loss of primary patency (peak systolic velocity ratio ≤ 2.4) at 1 and 2 years (days 365 and 730) was 89% and 80% for claudicants and 81% and 72% for CLTI.
• There was no statistical difference in patency between the two groups through 2 years, although there was a slight trend toward a worse outcome in patients with CLTI.

Dr. Parikh concluded that this subgroup analysis shows that the benefits of swirling flow previously established in claudicants are also relevant for CLTI patients and that these are compelling data that support the use of BioMimics 3D to manage patients with CLTI. Three-year follow-up continues, noted the VIVA announcement.