Professor Thomas Zeller (University Heart Centre Freiburg, Bad Krozingen, Germany) today presented the 36-month results from Veryan Medical’s MIMICS-2 study at CX 2020 Live.
MIMICS-2 is a prospective, single-arm, multi-centre clinical study to evaluate the safety and effectiveness of the BioMimics 3D® Vascular Stent System in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery. Conducted under an FDA Investigational Device Exemption (IDE) with concurrence of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) under the FDA/PMDA Harmonization By Doing collaboration, MIMICS-2 enrolled 271 subjects undergoing femoropopliteal intervention across 43 investigational sites in US, Japan and Germany. Professor Zeller, along with Dr Timothy Sullivan (Minneapolis, USA) and Professor Masato Nakamura (Tokyo, Japan), is a co-Principal Investigator.
Professor Zeller announced in the first presentation of the 36 month results, that the freedom from CDTLR at 3 years for the BioMimics 3D stent was 81%, a result that is comparable to the outcomes for DCB, DES and Supera, despite treating more challenging lesions and without the need for lesion preparation – providing ease-of-use simplicity and long-term benefits. Furthermore, sub-analyses presented, show that the CDTLR 3 year outcome was independent of the presence of severe calcium, total occlusions and long lesions.