Veryan, a Horsham, UK firm, received European clearance for its BioMimics 3D stent for implantation within the superficial femoral and proximal popliteal (femoropopliteal) arteries in the leg. The stent addresses the problem of vessel kinking due to articulation of the knee and helps blood move through the lumen in a more efficient manner.
This is achieved thanks to the stent’s helical structure that conforms more naturally to patients’ arterial geometry under stress and motion.
CE Mark approval was based on meeting the primary endpoints of the MIMICS study, a prospective randomised controlled trial comparing the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent in patients with peripheral artery disease undergoing femoropopliteal artery intervention. The BioMimics 3D stent demonstrated an excellent safety profile and promising clinical performance at both 6 and 12 month time points. Follow-up assessments of patients in the MIMICS study will continue for two years.
Interim data were presented at the VIVA (Vascular InterVentional Advances) meeting in Las Vegas in October 2012. At six months, all 50 patients that received treatment with the BioMimics 3D stent were free from clinically-driven target lesion revascularisation (CD TLR), and there were no deaths or amputations. Of the 36 patients treated with BioMimics 3D stents who had reached the 12-month follow-up time point, 33(91.7%) remained free from CD TLR, compared with 18 of the 21 (85.7%) from the control group who reached the same follow-up time point. The independent core lab has not detected any stent fractures to date in either treatment group.
Press release: Veryan Receives CE Mark Approval for BioMimics 3D™ Stent
Product page: BioMimics 3D Stent