Two-year follow-up data have shown that BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry, developed by Veryan Medical, 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.
The follow-up data of the MIMICS study were presented by principal investigator Thomas Zeller, Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany, at the annual Leipzig Interventional Course (LINC; Leipzig, Germany; 28–30 January).
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).
The BioMimics 3D stent features unique 3D helical centreline curvature to help the stented artery mimic the natural biomechanical performance of the femoropopliteal 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.
According to a press release, data presented at LINC 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 press release reports, 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. 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.
“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 Kaplan Meier 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”, comments Zeller.
The full 24-month data set will be available in April 2014.