Performance of Veryan Medical’s BioMimics 3D Helical Stent Assessed in Post Hoc Analysis of MIMICS Study
September 12, 2017—Veryan Medical Ltd. announced new data from the MIMICS study of the company’s BioMimics three-dimensional (3D) helical stent that were presented by Professor Thomas Zeller, MD, at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada. The BioMimics 3D vascular stent features a helical curvature to generate swirling blood flow.
In the MIMICS study, 76 patients with symptomatic peripheral artery disease were randomized 2:1 to the BioMimics 3D stent or the LifeStent (Bard Peripheral Vascular). Previously reported findings showed a statistically significant difference in primary patency through 24 months (P = .05) between BioMimics 3D and the straight stent control and in clinically driven target lesion revascularization between 12 and 24 months (P = .03).
The company reported that 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.
Investigators found that 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 demonstrated independence from each of the confounding factors of severity of calcium, lesion length, occlusion, and diabetes.
In the company's press release, Prof. Zeller commented that the data from the MIMICS randomized controlled trial supported the use of the BioMimics 3D swirling flow stent in primary stenting of complex lesions and point to the potential for complementary use with DCBs.
Veryan advised that further MIMICS studies are underway in the United States, Europe, and Japan that will provide an evolving and substantial database of safety and effectiveness outcomes in more than 1,300 patients undergoing femoropopliteal intervention.
Veryan Medical, which is based in the United Kingdom, has received European CE Mark approval for the BioMimics 3D stent system. The device is limited to investigational use only in the United States.