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 – (XX/50)

66%

Gender male – (XX/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

⇒ The majority of patients in both arms were in Rutherford category 3

⇒ There was no statistical difference between the 2 arms

Baseline Procedural Data

Diameter Stenosis – Pre-stent % ± SD 95% ± 8.0

95%

Diameter Stenosis – Post-stent % ± SD 6% ± 8.7

6%

Other Target Lesion Treatments Atherectomy –(39/518)

8%

Other Target Lesion Treatments Drug Coated Ballon – (259/518)

50

⇒ 50% of the lesions were treated with BioMimics 3D
and Drug Coated Balloon

Baseline Patient Demographics

Stented Segment Length Mean ± SD (mm) 131 ± 80.1

131

1 stent – (395/518)

76%

2-4 stents – (123/518)

25%

⇒ More than 1 stent used in 25% of lesions

MIMICS-3D European Registry Results

Technical Success (procedure)

99%

Procedural Success

97%

Primary Endpoint – 30-Day Safety (486/493) Freedom from MAE

99%

Primary Endpoint – 12-month Effectiveness (399/448) Freedom from CDTLR

89%

3-Year Results

36-Month KM Freedom from loss of Primary Patency

71%

36-Month KM Freedom from CDTLR

78%

Stent fracture – (3/676)

0.4%

Kaplan-Meier Freedom from CDTLR over 3 years

Comparison of KM freedom from CDTLR with
and without DCB

⇒ No statistical difference in CDTLR between DCB
and no-DCB cohorts

MIMICS Clinical Program

Enrolling progressively longer and more complex lesions

Mean ± SD (mm) MIMICS-RCT MIMICS-2 MIMICS-3D
Lesion Length 66 ± 29 81 ± 38 126 ± 91
Stented Segment Length 99 ± 30 112 ± 36 131 ± 80
CTO 44% 30% 57%
Mod/Severe Ca++ 52% 46% 53%
CLTI 6% 6% 24%

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

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.