Clinical evaluation of the BioMimics 3D Stent

Veryan has completed enrolment in the MIMICS study; a multicentre clinical evaluation of the safety and performance of the BioMimics 3D stent and delivery system in subjects with peripheral artery disease undergoing femoropopliteal artery intervention. Patient enrollment in MIMICS was initiated in Germany in February 2010. The study Principal Investigator is Prof. Dr. med. Thomas Zeller.

The MIMICS study is comprised of an initial First in Human (FIH) cohort of 10 subjects that provided clinical safety evidence at 30 days to support commencement of a randomised study. In the randomised phase, 76 subjects were randomised in a 2:1 ratio to receive either the BioMimics 3D stent (N=50) or a straight Nitinol comparator stent (N=26).

A prospectively defined interim analysis of clinical performance data from the MIMICS study provided the basis for CE Mark application. CE Mark was awarded in October 2012. Follow up of patients in the MIMICS study will continue over a 24 month period.