FDA Approves Veryan Medical's BioMimics 3D Vascular Stent System
October 4, 2018—Veryan Medical Ltd. announced that it has received FDA premarket approval for its BioMimics three-dimensional (3D) vascular stent system for the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.
According to the company, the device's 3D helical shape is designed to impart natural curvature to the diseased femoropopliteal artery to promote swirling flow and elevate wall shear, which has a protective effect on the endothelium. The helical centerline stent also accommodates the complex biomechanical challenge associated with stenting this anatomically mobile artery.
FDA approval was supported by the 12-month interim safety and effectiveness results from the company’s MIMICS-2 clinical study. Conducted under an FDA-approved investigational device exemption, MIMICS-2 evaluated the BioMimics 3D system in patients with peripheral artery disease undergoing endovascular intervention in the femoropopliteal artery. The study enrolled 271 patients at 43 investigational sites in the United States, Japan, and Germany.
Veryan reported that the MIMICS-2 study met both of its primary endpoints of safety and effectiveness. Freedom from major adverse events at 30 days was 99.6% (268/269) and Kaplan-Meier estimates of freedom from loss of primary patency and clinically driven target lesion revascularization were 83% and 88%, respectively, at 12 months. No stent fractures were detected in core laboratory imaging review. The study's Principal Investigators are Timothy M. Sullivan, MD, in the United States, Masato Nakamura, MD, in Japan, and Thomas Zeller, MD, in Germany.