April 30, 2019
Two-Year MIMICS-2 Data Support Veryan's BioMimics 3D Stent System in Femoropopliteal Arteries
May 1, 2019—At the 2019 Charing Cross Symposium, held April 15–18 in London, United Kingdom, Timothy Sullivan, MD, presented data from the MIMICS-2 trial that showed that the BioMimics three-dimensional (3D) stent (Veryan Medical Ltd.) remains safe and effective for patients with symptomatic atherosclerotic disease of the femoropopliteal arteries at 2 years after implantation. Dr. Sullivan is a Principal Investigator of the trial.
According to the Charing Cross Symposium announcement, MIMICS-2 is an international investigational device exemption (IDE) study to evaluate the safety and efficacy of the BioMimics 3D stent system in patients undergoing endovascular intervention to relieve obstructive or occlusive disease in the femoropopliteal artery. The 3-year, prospective, single-arm trial is tracking outcomes in 271 patients with a mean age at baseline of 68.4 years, across 43 sites in the United States, Germany, and Japan.
The BioMimics 3D stent, which mimics natural vascular curvature, is designed to promote natural swirling blood flow and increase wall shear stress to protect the endothelium, as well as enable coil-spring shortening of the stented segment during knee bending to reduce the risk of stent fracture.
Dr. Sullivan reported that the Kaplan-Meier estimate of survival from clinically driven target lesion revascularization (CD-TLR) at 24 months was 84.2%, which is comparable with the performance at 2 years of drug-eluting stents (DESs) and drug-coated balloons (DCBs). As noted in the announcement, the MIMICS-2 patient cohort included a greater proportion of challenging cases than in IDE trials for DES/DCB.
The Charing Cross Symposium announcement noted that positive outcomes were achieved independent of lesion complexity. For example, at the start of MIMICS-2, 45.9% of patients had moderate to severe lesion calcification. The Kaplan-Meier estimate of survival from CD-TLR at 24 months for patients in this group was 85.5%. x-ray imaging confirmed that there were no cases of stent fracture in any of the MIMICS-2 subjects, including those who have reached 3-year follow-up.
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. These showed that the primary safety endpoint of freedom from major adverse events (death, major amputation, or CD-TLR) at 1 month was reached for 99.6% of patients and the 12-month freedom from loss of primary patency rate was 81.9%, advised the Charing Cross Symposium press release.