The Mimics Study is a prospective, part randomized study; an initial roll-in registry of 10 subjects treated with BioMimics 3D followed by a randomized assignment to treatment with BioMimics 3D or Control on a 2:1 basis for 76 subjects.~The primary purpose of the study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease based on:~Safety; measured by freedom from major adverse events determined at 30 days after the procedure, compared to historic controls.~Performance; measured by freedom from clinically driven TLR at 6 months, compared to historic controls.
Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.