November 4, 2019
One-Year MIMICS-3D Registry Results Support Veryan's BioMimics 3D Stent
November 5, 2019—VIVA Physicians announced that 1-year results from the European MIMICS-3D registry, evaluating the BioMimics three-dimensional (3D) nitinol stent (Veryan Medical Ltd.), were presented by Michael Lichtenberg, MD, during a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
With a 3D helical centerline to provide biomechanical stability and swirling blood flow, the BioMimics 3D device is designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. In October 2018, Veryan Medical announced FDA premarket approval for the BioMimics 3D vascular stent system for the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.
Dr. Lichtenberg noted the studies of BioMimics 3D:
- The MIMICS randomized controlled trial (RCT), which included patients who received either a BioMimics 3D helical stent or a straight stent control, showed Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) at 1 year of 91% for patients treated with BioMimics 3D.
- MIMICS-2, conducted in the United States, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints, and the 1-year Kaplan-Meier estimate of freedom from CD-TLR was 88%.
- MIMICS-3D registry is now investigating outcomes in patients with longer, more complex lesions; complementary use with drug-coated balloons occurred in 50% of procedures.
As summarized in the VIVA announcement, MIMICS-3D enrolled 507 patients at 23 sites. The primary safety endpoint is a composite of major adverse events (MAEs) or CD-TLR through 30 days. The primary outcome measure for effectiveness is freedom from CD-TLR through 12 months. An independent clinical events committee adjudicated MAEs.
Dr. Lichtenberg reported the following:
- 98% technical success of the BioMimics 3D procedure as assessed by the operator
- 87% (322/370) of patients showed improvement of ≥ 1 Rutherford category at 1 year compared with baseline
- 89% freedom from CD-TLR at 12 months, which aligns with results from the MIMICS RCT and MIMICS-2 studies, despite treatment of more complex disease
- No difference in CD-TLR for patients treated with or without a drug-coated balloon and BioMimics 3D (89.5% and 88.5%, respectively; P > .88)
These three studies confirm that imparting a helical shape onto the vessel with BioMimics 3D and imparting swirling flow improves outcomes and suggest that swirling flow is nature’s alternative to drug elution, concluded Dr. Lichtenberg at VIVA.