Twelve-Month MIMICS-2 Data Presented for Veryan Medical's BioMimics 3D Stent
January 30, 2018—Veryan Medical Ltd. announced that Professor Thomas Zeller, MD, presented the 12-month safety and efficacy data from the MIMICS-2 study at LINC 2018: the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
MIMICS-2 is a prospective, single-arm, multicenter clinical study designed to evaluate the safety and effectiveness of the company's BioMimics three-dimensional (3D) vascular stent system in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery. The study enrolled 271 patients undergoing femoropopliteal intervention across 43 investigational sites in the United States, Japan, and Germany. The study's Coprincipal Investigators are Timothy Sullivan, MD, in the United States; Professor Masato Nakamura, MD, in Japan; and Prof. Zeller in Germany.
The company advised that the trial is being conducted under an investigational device exemption from the US Food and Drug Administration with concurrence of the Japanese Pharmaceuticals and Medical Devices Agency under those agency's Harmonization By Doing collaboration.
At LINC, Prof. Zeller announced that both the primary safety and effectiveness endpoints were met: there were no stent fractures, the Kaplan-Meier estimate of freedom from loss of primary patency at 12 months was 81.9% at day 365, and the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization at 12 months was 88.8%.
Prof. Zeller added that the MIMICS-2 results reinforce the results of the company's earlier MIMICS-RCT randomized controlled trial in a larger, more challenging patient population. The BioMimics 3D primary patency result at 12 months is similar to those reported for drug-eluting stents and drug-coated balloons, which suggests that natural swirling flow is an alternative to antiproliferative drugs.
According to the company, the BioMimics 3D stent has a unique three-dimensional helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, promoting swirling flow and elevating wall shear, which has a protective effect on the endothelium. The BioMimics 3D stent has European CE Mark approval. In the United States, the device is limited by law to investigational use only.