Veryan Medical has announced completion of enrolment of the 500th patient in the MIMICS-3D pan-European registry, a prospective, multicentre, observational registry to evaluate the BioMimics 3D Self-Expanding Stent System in the treatment of femoropopliteal artery disease.
The registry is evaluating safety, effectiveness and device performance within a real-world clinical population in combination with other therapies, including drug-coated balloons and atherectomy devices, in 25 hospitals across Europe.
The MIMICS-3D Registry principal investigator, Michael Lichtenberg (Arnsberg, Germany) says: “I am delighted that this significant landmark in the MIMICS-3D registry has been reached. The clinical sites have been extremely committed to both the device and the study and the speed of enrolment and quality of the data being collected are impressive. I would like to extend my thanks to all involved for getting us to this stage.”
Veryan’s CEO Chas Taylor adds: “The fact that 500 patients were enrolled in just 18 months is testimony to the commitment of the participating clinical sites. I’d like to thank Dr Lichtenberg the principal investigator for leading this important study and all of the investigators and the research personnel who contributed. To date, the MIMICS clinical programme has gathered impressive data on over 1000 patients in a growing database of clinical experience that is providing significant validation of the unique helical shape of BioMimics 3D and the benefits of Swirling Flow. It is notable that there have been no fractures confirmed in any of these clinical study devices nor, indeed, in any BioMimics 3D device since the first one was implanted in February 2010.”