New significant outcomes from the Mimics study have been presented at the 15th annual conference on Vascular Interventional Advances (VIVA; 11-14 September, Las Vegas, USA). The data were presented by Thomas Zeller (Unversitaets Herzzentrum, Freiburg, Bad-Krozingen, Germany).
The BioMimics 3D vascular stent (Veryan) with unique helical curvature to generate swirling blood flow was evaluated in the Mimics study, which randomised 76 patients with symptomatic peripheral artery disease 2:1 to either BioMimics 3D swirling flow stent or LifeStent (Bard). A statistically significant difference was observed in primary patency through 24 months (p=0.05) between BioMimics 3D and the straight stent control and in clinically-driven target lesion revascularisation between 12 and 24 months (p=0.03).
A post-hoc analysis was conducted to assess how performance of the BioMimics 3D stent was affected by the outcome-confounding factors of calcification, lesion length, occlusion and diabetes. The presence of target lesion calcification did not affect curvature of the BioMimics 3D stented segment nor the generation of swirling flow within. Kaplan-Meier survival estimates for freedom from loss of primary patency through 24 months in femoropopliteal segments treated with BioMimics 3D stents demonstrate independence from each of the confounding factors of severity of calcium, lesion length, occlusion and diabetes.
Zeller commented that the Mimics’ randomised controlled trial data “support use of the BioMimics 3D swirling flow stent in primary stenting of complex lesions and point to potential for complementary use with drug-coated balloons”. Chas Taylor, Veryan’s CEO said, “Further Mimics studies are underway in the USA, Europe and Japan to provide an evolving and substantial database of safety and effectiveness outcomes in more than 1,300 subjects undergoing femoropopliteal intervention.”