Veryan Medical Completes Enrollment in MIMICS-2 Study

October 24, 2016—Veryan Medical Ltd. announced the completion of patient enrollment in the MIMICS-2 clinical study of its BioMimics three-dimensional (3D) self-expanding stent system, which features the company’s 3D helical geometry. 

According to the company, the prospective multicenter interventional study is designed to evaluate the safety and effectiveness of the BioMimics 3D system in the treatment of patients with symptomatic femoropopliteal disease. The MIMICS-2 study enrolled 271 patients at 47 investigational sites in Germany, the United States, and Japan.

Veryan Medical advised that the MIMICS-2 study is being conducted under a US Food and Drug Administration investigational device exemption, with Japanese Pharmaceuticals and Medical Devices Agency concurrence under the “Harmonization By Doing” initiative to provide safety and effectiveness data that are intended to support future marketing approval applications for the BioMimics 3D self-expanding stent system in the United States and Japan.

In September, Veryan Medical announced commencement of enrollment in the MIMICS-3D prospective, multicenter, observational registry to evaluate the BioMimics system in the treatment of peripheral artery disease. The registry will evaluate safety, effectiveness, and device performance within a real-world clinical population in a minimum of 500 patients across Europe, where the device received CE Mark approval in 2012 for treatment in the superficial femoral and proximal popliteal arteries.