MIMICS RCT

A randomised study comparing safety and effectiveness of the BioMimics 3D Vascular Stent
System to a straight stent control.

  • PI: Thomas Zeller, MD
  • Core laboratories: ultrasound; angiography; X-ray Clinical Event Committee (CEC) adjudication
  • 2-year follow up
  • 8 German investigational sites
  • 76 patients enrolled with a 2:1 randomisation

Baseline Patient Demographics

  • BioMimics 3D enrolled population N=50
  • Control Stent enrolled population N=26

BioMimics 3D

Control Stent

P value

Gender male – (33/50)

66%

Gender male – (17/26)

65%

1.0

Age – Mean years ± SD (N) – 68 ± 10.4

0yrs

Age – Mean years ± SD (N) – 67 ± 8.9

0yrs

0.66

Rutherford Category

BioMimics 3D

Control Stent

P value

Rutherford category 1 – (3/50)

6%

Rutherford  category 1 – (1/26)

4%

1.00

Rutherford category 2 – (7/50)

14%

Rutherford  category 2 – (1/26)

4%

0.74

Rutherford category 3 – (37/50)

74%

Rutherford  category 3 – (23/26)

88%

0.27

CLTI – (3/50)

6%

CLTI – (1/26)

4%

1.00

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Lesion Characteristics

BioMimics 3D

Control Stent

P value

Lesion Length (mm) – 66 ± 29

66 ± 29

Lesion Length (mm) – 63 ± 28

63 ± 28

0.66

Occlusion (Total) – 44%

44%

Occlusion (Total) – 46%

46%

1.00

Calcification (Moderate to Severe) – 52%

52

Calcification (Moderate to Severe) – 58%

58

0.81

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Primary Patency

Kaplan Meier Survival Estimate from Loss of Patency

Defined as PSVR >2.0, or  where angiography reveals >50% diameter stenosis;  or adjudicated clinically-driven TLR

Clinically-Driven Target Lesion Revascularisation

Kaplan Meier Estimate of Survival from clinically-driven TLR determined through Independent Event Adjudication

 

Long Term TLR Benefit

12-Month Landmark Analysis

Kaplan Meier Estimate of Survival from clinically-driven TLR determined through Independent Event Adjudication

Summary

MIMICS-RCT Provided the first clinical proof supporting the durable outcome benefit arising from the BioMimics 3D stent compared to a straight nitinol stent

  • Freedom from loss of Primary Patency at 2 years
    • 72% for BioMimics 3D vs 55% for straight control stents (P=0.05).
  • Freedom from CDTLR
    • 91% for BioMimics 3D maintained out to 2 years.
  • Core lab X-ray imaging review confirmed 0% stent fractures at 2 years.
  • Improvement in Rutherford Category
    • 88% of patients treated with BioMimics 3D experienced an improvement of one or more Rutherford category at 2 years vs baseline.

Data on file at Veryan Medical

All percentages are rounded to a whole number

Discover The BioMimics 3D Vascular Stent System

3D Helical Stent Design

The BioMimics 3D Vascular Stent System has a unique 3D helical geometry which imparts a gentle helical shape to the stented artery.

Technical information

Technical Information for the BioMimics 3D Vascular Stent System.

BioMimics 3D® Vascular Stent System

The BioMimics 3D Vascular Stent System has a unique 3D helical geometry which imparts a gentle helical shape to the stented artery.