June 9, 2020
Veryan Medical's MIMICS-2 36-Month Data Presented at CX 2020
June 9, 2020—Veryan Medical Ltd., an Otsuka Medical Devices company, announced that the 36-month results from the company's MIMICS-2 study were presented by Professor Thomas Zeller, MD, at CX 2020 Live, the virtual Charing Cross Symposium, which takes place online with programs every Tuesday and Thursday from May 26 to June 25.
According to the company, MIMICS-2 is a prospective, single-arm, multicenter clinical study evaluating the safety and effectiveness of the BioMimics three-dimensional (3D) vascular stent system in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery.
The study enrolled 271 patients undergoing femoropopliteal intervention at 43 investigational sites in the United States, Japan, and Germany. The coprincipal investigators are Prof. Zeller; Timothy Sullivan, MD; and Professor Masato Nakamura, MD.
Prof. Zeller reported that the freedom from clinically driven target lesion revascularization (CD-TLR) at 3 years for the BioMimics 3D stent was 81%, a result that is comparable to the outcomes for drug-coated balloons, drug-eluting stents, and the Supera peripheral stent system (Abbott), despite treating more challenging lesions and without the need for lesion preparation.
Additionally, subanalyses data showed that the CD-TLR 3-year outcome was independent of the presence of severe calcium, total occlusions, and long lesions.
MIMICS-2 is conducted under an FDA investigational device exemption with concurrence of the Japanese Pharmaceuticals and Medical Devices Agency under the Harmonization By Doing regulatory collaboration. The BioMimics 3D stent has received CE Mark approval in Europe and premarket approval in the United States and Japan, advised Veryan Medical.