MIMICS-2 Study Begins for Veryan Medical's BioMimics 3D Stent System

July 1, 2015—Veryan Medical Ltd. announced the commencement of the MIMICS-2 study of the company’s BioMimics 3D stent system, which features a nitinol stent with a three-dimensional (3D) helical geometry to treat disease of the femoropopliteal artery.

European principal investigator Prof. Thomas Zeller, MD, enrolled the study’s first patient at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany. The United States principal investigator is Timothy Sullivan, MD, who is Chairman of Vascular/Endovascular Surgery at Minneapolis Heart Institute, Abbott Northwestern Hospital, in Minneapolis, Minnesota.

According to the company, MIMICS-2 is a prospective, single-arm, multicenter clinical trial that will enroll 280 patients in up to 40 sites in the United States and Germany. Investigators will evaluate the BioMimics 3D stent system against the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.

MIMICS-2 is being conducted under an investigational device exemption approved by the US Food and Drug Administration to provide data in support of a United States premarket approval application.

Prof. Zeller, who was also the principal investigator of the MIMICS randomized controlled study, commented in the company’s press release, “The MIMICS study data suggested the existence of a patency protective effect provided by the biomimetic characteristics of the BioMimics 3D stent. I am delighted that we have enrolled the first subject today in MIMICS-2 so that BioMimics 3D can be studied in a larger patient cohort.” 

Veryan stated that in the MIMICS study, the Kaplan-Meier survival estimate of freedom from loss of primary patency at 2 years was 72% for BioMimics 3D patients versus 55% for the control arm. The difference in survival estimate between the two groups by log-rank test was significant (P < .05). The company also noted that there was no increase in the Kaplan-Meier estimate of clinically driven target lesion revascularization rate in the BioMimics arm between 12 and 24 months (9% at both time points) compared to a threefold increase (8% at 12 months and 24% at 24 months) in the straight-stent control arm. Prof. Zeller presented the 2-year data from the MIMICS study in November at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.

The BioMimics 3D’s helical curvature is designed to impart natural curvature to the diseased artery, promoting secondary flow and elevated wall shear stress, which has a protective effect on the endothelium. It also enables coil-spring shortening of the stented segment during knee flexion and mitigates the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury, stated the company.