We’ve covered Veryan Medical’s BioMimics 3D™ stent before on our pages, most recently last October when it saw encouraging 12 month data presented at the VIVA13 conference in Las Vegas. Now two-year follow-up data has shown that the stent with its unique three-dimensional helical geometry, provides an improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention for symptomatic peripheral arterial disease.
Background
Veryan Medical’s BioMimics 3D stent features unique 3D helical centreline curvature to help the stented artery mimic the natural biomechanical performance of the femoropopliteal artery during knee flexion and extension. This stent is also designed to promote swirling blood flow and elevated wall shear stress in the stented segment, which preclinical studies have shown to significantly reduce the formation of neointimal hyperplasia, potentially conferring a patency protective effect.
The MIMICS study is a prospective, 2:1 randomised controlled trial, conducted at eight German investigational centres, with an independent imaging core lab, comparing the safety and efficacy of the BioMimics 3D™ stent with a straight nitinol stent (92% of subjects in the control arm were treated with Bard LifeStent).
At the annual Leipzig Interventional Course (LINC), data presented by Principal Investigator Professor Thomas Zeller, Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany, on behalf of the MIMICS investigators, showed the Kaplan Meier (KM) survival analysis of freedom from loss of primary patency at two years was 75.6% for BioMimics 3D subjects vs. 56.0% for the control group (P=0.06).
In line with the preclinical observations, the preliminary two-year data from the MIMICS study point to a correlation between primary patency and stent curvature, measured using bi-planar X-ray imaging in straight and bent knee positions. Veryan says its BioMimics 3D stented segments showed greater curvature in knee extension (P=0.02) and flexion (P=0.02) compared with the control, providing a basis for improved haemodynamics that may underlie the longer term patency protective effect seen with BioMimics 3D. No stent fractures have been detected by the study core lab.
Investigator comments
“The latest 24-month data for patients treated with the BioMimics 3D stent continue to suggest that the flow effects produced by its helical design are contributing to an improved outcome compared to that achieved with the straight control stent. The KM curve for freedom from loss of primary patency with BioMimics in the 12-24 month period shows separation from that of the control stent, with the prospect of a statistically significant difference once the few remaining subjects are assessed over the next two months”, commented Professor Zeller.
Company comments
“Data from the 24-month assessment visits in the MIMICS Study are continuing to provide a highly favourable and competitive foundation for BioMimics 3D commercialization and for further clinical investigation to support Veryan’s US strategy”, added Veryan Chief Executive Chas Taylor. “We anticipate that the full 24-month data set will be available in April 2014.”
Source: Veryan Medical Systems, Ltd.
published: February 6, 2014 in: Clinical Studies/Trials, Vascular