Interim Data From the MIMICS-3D Registry Presented for Veryan’s BioMimics 3D Stent
November 6, 2018—Veryan Medical Ltd. announced interim data from the MIMICS-3D registry of the company’s BioMimics three-dimensional (3D) helical stent that were presented by Professor Thomas Zeller, MD, at the VIVA 18, Vascular Interventional Advances, conference held November 5–8 in Las Vegas, Nevada. The BioMimics 3D is a nitinol stent designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. Addition of a unique 3D helical centerline provides the advantages of biomechanical stability and swirling blood flow.
BioMimics 3D, which recently received FDA premarket approval, was evaluated in the MIMICS randomized controlled trial (RCT), in which subjects received either a BioMimics 3D helical stent or a straight stent control. Those treated with BioMimics 3D had better primary stent patency at 24 months (P < .05). A second study, MIMICS-2, conducted in the United States, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints, and longer-term outcome data are accruing in the ongoing follow-up through 3 years.
A European registry (MIMICS-3D) is now investigating outcomes in a population consisting of sicker patients with longer, more complex lesions; complementary use with drug-coated balloons occurred in 50% of procedures. MIMICS-3D enrolled 505 subjects at 23 sites. The primary safety endpoint is a composite of major adverse events (MAEs) or clinically driven target lesion revascularization (CD-TLR) through 30 days. Primary outcome measure for effectiveness is freedom from CD-TLR though 12 months. An independent clinical events committee adjudicates MAEs.
Technical success of the BioMimics 3D procedure as assessed by the operator for the entire enrolled population was 98%. Interim data on the first 200 enrolled patients showed that the percentage of subjects with improvement of at least one Rutherford category or more compared to baseline was 88.5% (115/157); 12-month freedom from TLR is 90%, which closely tracks the values for the MIMICS RCT and MIMICS-2 study, despite treatment of more complex disease. In all three studies, there have been no confirmed stent fractures. These emerging data continue to support the hypothesis that intentionally rendering the stented femoropopliteal artery segment helical (and thus imparting swirling blood flow) improves the outcome of peripheral intervention.