We last covered UK vascular outfit Veryan Medical in October 2013, when the company was touting the presentation of 12 month clinical data supporting its novel BioMimics 3D™ peripheral vascular stent. Now they tell us the study, tagged MIMICS, has reached the two year point and will see results presented at the 15th Annual New Cardiovascular Horizons (NCVH) Conference taking place between May 28th and 30th in New Orleans.
It’s a clever old thing, the Veryan Biomimics 3D stent, designed on the principle that a 3D helical configuration actually elevates wall shear stress in the stented segment and as such has the potential to reduce the formation of neointimal hyperplasia compared to straight stents. Indeed preclinical studies have borne that theory out. The helical curvature of the BioMimics 3D stent is also designed to help the stented vessel mimic the natural biomechanical performance of the femoropopliteal artery during knee flexion, mitigating the risk of stent fracture and vessel kinking.
The Mimics study is a prospective, randomised, multicentre controlled trial conducted at eight German investigational centers. A total of 76 patients were enrolled and randomized 2:1 (50 BioMimics 3D v 26 Control) in patients undergoing femoropopliteal artery intervention. Supported by an independent core lab, Mimics’ investigators compared the safety, efficacy and vascular hemodynamics of the BioMimics 3D stent to those of a straight nitinol stent (24/26 control subjects were treated with C.R. Bard’s LifeStent).
Previously presented Mimics’ data have provided evidence for a patency-protective effect in patients treated with BioMimics 3D. These preliminary data showed a clear separation favouring BioMimics 3D over control stents in the two-year Kaplan Meier survival estimates for freedom from clinically driven target lesion revascularization (TLR).
Principal Investigator Professor Thomas Zeller, Head of the Department of Angiology at the Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany, will present the data during the New Technology session on Friday, May 30th. Prof. Zeller’s presentation will provide the first disclosure of the full two-year data set from this important comparative study.
“Mimics’ data have continued to suggest that the flow effects produced by the helical design are contributing to an improved outcome compared to that achieved with the straight control stent. I will present the final two-year primary patency and TLR results at the NCVH meeting, and use evidence from the Mimics database to differentiate the performance characteristics of a biomimetic stent from those of a straight stent”, commented Professor Zeller.
“We are very grateful to Professor Zeller and the Mimics Investigators for the support that has enabled Veryan to complete this benchmark evaluation of our biomimetic 3D helical stent technology. We believe this advanced stent design offers outstanding benefits in femoropopliteal use and also has potential for innovation in many other areas of endovascular intervention. Presentation of the two-year Mimics’ results represents a major step forward in this endeavour”, added Veryan Chief Executive Chas Taylor.
Veryan has received CE Mark approval for the BioMimics 3D stent and plans to commercialise the stent later this year.
Source: Veryan Medical Ltd.