BioMimics 3D® Vascular Stent System
Clinical Evidence

The MIMICS Clinical Programme:

An evolving database of the safety and effectiveness of the BioMimics 3D Vascular Stent System. Gathering clinical evidence from a “real world” patient population from single de novo to complex, long and severely calcified lesions.

MIMICS-RCT

A randomised study comparing safety and effectiveness of the BioMimics 3D Vascular Stent System to a straight control stent. The difference in freedom from loss of primary patency was statistically significant through 2 years, favouring the BioMimics 3D Vascular Stent System (72% vs 55% at two years, log-rank test P=0.05). Between 12 and 24 months, there were no additional cases of CDTLR in patients with the BioMimics 3D Vascular Stent System (91% at1 & 2 years), while the number of cases of CDTLR with the control straight stent increased threefold (log-rank test P=0.03)1. There were no stent fractures at 2 years.2

MIMICS-2

A multicentre, international (USA, Japan and Germany) IDE study. At 3 years follow-up BioMimics 3D demonstrated continuing benefit with CDTLR showing comparable outcomes to DES/DCB. Core Lab X-ray imaging review confirmed 0% stent fracture in any MIMICS-2 subject treated with BioMimics.
MIMICS-2 represents a more challenging patient population than in DES/DCB pivotal trials.​3,4

MIMICS-3D

A prospective observational registry evaluating the BioMimics 3D Vascular Stent System in a real-world clinical population with a dedicated subgroup analysis of device performance as a complementary treatment in procedures involving drug-coated balloons. MIMICS 3D enrolled 507 patients across 23 clinical sites in Europe.

MIMICS-3D USA

A prospective, multicentre observational study evaluating the safety, effectiveness and device performance of the BioMimics 3D Vascular Stent System within a real-world clinical population of patients undergoing femoropopliteal intervention. MIMICS-3D-USA will enrol more than 500 patients in 40 clinical sites across the United States. Commencing late 2020

1.Data on file at Veryan Medical treatment in procedures involving drug-coated balloons.
2. Zeller T. et al; Circ Cardiovasc Interv. 2016;9
3. Kenneth Rosenfield et al :N Engl J Med 2015;373:145-53. DOI: 10.1056/NEJMoa1406235
4. Michael D. Dake et al : Circ Cardiovasc Interv. 2011;4:495-504

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