MIMICS-3D 2-Year Clinical Outcomes for the BioMimics 3D Stent in a Real-World Population

Purpose: The BioMimics 3D Vascular Stent System (Veryan Medical) delivers a nitinol stent designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. BioMimics 3D’s unique three-dimensional (3D) helical centerline provides biomechanical stability, promotes swirling blood flow, and beneficially elevates wall shear stress. BioMimics 3D was evaluated in the MIMICS randomized controlled trial (RCT) in which participants undergoing femoropopliteal intervention received the BioMimics 3D helical stent or a straight stent control (LifeStent; Becton, Dickinson and Co.). Patients treated with BioMimics 3D had better primary stent patency (P < 0.05) and threefold fewer revascularizations through 24 months. A second study, MIMICS-2, conducted under an IDE in the United States, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints and freedom from clinically driven target lesion revascularization (CDTLR) at 3 years was 81%. The MIMICS-3D European Registry is investigating outcomes through 3 years in a real-world population with more challenging, complex lesions than were enrolled in the MIMICS-RCT and MIMICS-2 trials.

Materials and Methods: MIMICS-3D enrolled 507 participants treated with BioMimics 3D at 23 sites. The mean age was 70 years; 37% of participants had diabetes, 24% had chronic limb ischemia, 38% had moderate to severe calcification, and 57% had chronic total occlusions (CTOs). The mean lesion length was 127 mm. The technical success rate was 99%. An independent clinical events committee adjudicates major adverse events (MAEs), including death and potential device-related events. The primary safety endpoint is a composite of MAE, comprising death, major index-limb amputation, or CDTLR through 30 days. The primary outcome measure for effectiveness is freedom from CDTLR through 12 months.

Results: Freedom from CDTLR at 1 and 2 years was 91% and 83% respectively and 1- and 2-year primary stent patency rates (≤2.0) were 87% and 76%, respectively. These outcomes were independent of lesion length and the presence of severe calcium or CTO.

Conclusions: Data from MIMICS-3D validate those from other MIMICS investigations into the performance of the BioMimics 3D Vascular Stent System and support the hypothesis that imparting nonplanar curvature to the femoropopliteal artery to promote swirling blood flow and increase wall shear stress results in clinical outcomes that are comparable to those of drug-coated and drug-eluting devices, even in challenging lesions.