February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS-2 IDE study, a prospective, single-arm, multi-center clinical study to evaluate the safety and effectiveness of the BioMimics 3-D 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 the concurrence of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) under the FDA/PMDA Harmonisation By Doing collaboration, MIMICS-2 enrolled 271 subjects undergoing femoropopliteal intervention across 43 investigational sites in the U.S., Japan and Germany.
Zeller, who along with Timothy Sullivan (Minneapolis, USA) and Professor Masato Nakamura (Tokyo, Japan) is a co-principal investigator, presented the MIMICS-2 12-month safety and efficacy data at LINC 2018 in Leipzig, Germany. He announced for the first time that both the primary safety and effectiveness endpoints were met; there were no stent fractures; the Kaplan-Meier estimate of freedom from loss of primary patency at 12 months was 81.9 percent at day 365 and the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD TLR) at 12 months was 88.8 percent. He commented further that these MIMICS-2 results reinforce the results of the company’s earlier MIMICS-RCT study in a larger, more challenging patient population. The BioMimics 3-D primary patency result at 12 months is similar to those reported for drug-eluting stents and drug-coated balloons which suggests that natural swirling flow is an alternative to antiproliferative drugs.
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