Full 2-Year MIMICS Data Confirm Long-Term Patency Protection With Veryan's BioMimics 3D Stent

May 30, 2014—Veryan Medical, Ltd. announced that full 2-year data from the MIMICS study were presented at the 15^th annual New Cardiovascular Horizons (NCVH) conference in New Orleans, Louisiana.

The data, presented by MIMICS principal investigator Prof. Thomas Zeller, MD, of Universitäts-Herzzentrum in Freiburg-Bad Krozingen, Germany, confirm that the company’s BioMimics 3D, a nitinol stent with a 3D helical geometry, provides a significant improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention.

Prof. Zeller presented the initial 2-year MIMICS data in February at LINC 2014: the Leipzig Interventional Course in Leipzig, Germany.

According to Veryan, the MIMICS study is a prospective, randomized, multicenter controlled trial conducted at eight German investigational centers and supported by an independent core lab. A total of 76 patients were enrolled and randomized 2:1 (50 BioMimics 3D vs 26 control) in patients undergoing femoropopliteal artery intervention. The study investigators compared the safety, efficacy, and vascular hemodynamics of the BioMimics 3D stent to straight nitinol stents (24 of the 26 control subjects were treated with LifeStent [Bard Peripheral Vascular, Inc.]).

The BioMimics 3D stent incorporates Veryan’s 3D helical technology in a stent design that promotes natural swirling blood flow to elevate wall shear stress, which has been shown to reduce neointimal hyperplasia and improve the biomechanical performance of the femoropopliteal artery during knee flexion, mitigating the risk of stent fracture and vessel kinking.

The company reported that there are two key findings. First, the Kaplan-Meier survival analysis of freedom from loss of primary patency at 2 years was 72% for BioMimics 3D patients versus 55% for the control group, which was a significant difference (P = .0497). Second, there was no increase in the clinically driven target lesion revascularization (CDTLR) rate in the BioMimics arm between 12 and 24 months (9% at both time points) compared to an increase of 16% (8% at 12 months and 24% at 24 months) in the control arm.

According to Veryan, the data indicate a correlation between primary patency and stent curvature. BioMimics 3D stented segments showed significantly greater curvature (P = .02) compared with the control, providing improved blood flow and elevated wall shear, which may explain the longer-term patency-protective effect seen with BioMimics 3D. No stent fractures were detected by the independent core lab.

In the company’s press release, Prof. Zeller commented, “The final 24-month data for the BioMimics 3D stent confirm that the flow effects produced by its helical design are contributing to an improved outcome compared to that achieved with the straight control stents. The results of the MIMICS study show a significantly greater freedom from loss of primary patency with BioMimics in the 24-month Kaplan-Meier survival analysis. Importantly, there was no change in the rate of clinically driven target lesion revascularization in the 12- and 24-month follow-ups for BioMimics 3D, and this longer-term benefit appears to correlate with a trend to lower peak systolic velocities. Overall, these data suggest that a biomimetic stent with 3D helical curvature may provide a new performance benchmark in femoropopliteal stenting.”

The BioMimics 3D stent received CE Mark approval and will be launched later this year. Veryan, which is based in the United Kingdom, noted that the company’s development of the BioMimics 3D device was based on pioneering research into the link between blood flow mechanics and vascular disease by Prof. Colin Caro, MD, at Imperial College London.