Failure Mode Why VasQ Clinical Data The Procedure

VasQ

Arteriovenous Fistula (AVF) Failure Mode

A biological response to hemodynamic and mechanical stress

Hemodynamic Stress
A turbulent flow profile leads to areas of low wall shear stress associated with development of stenosis or thrombosis 1
Mechanical Stress
Excessive transmural pressure leads to medial hypertrophy1
Inward (Stenotic) Remodeling
The combined effect leads to a high propensity of inward wall thickening of the vein that results in AVF failure for many patients
Image from Swinnen et al. J Vasc Surg 2015;61:436-42
Image from Swinnen et al. J Vasc Surg 2015;61:436-42

Why VasQ

VasQ is the only solution currently available2 that addresses both hemodynamic and mechanical stress to create more usable fistulas

Promote Outward (Dilative) Remodeling

The nitinol external support controls the remodeling at the anastomosis to promote outward wall thickening downstream for eventual use in hemodialysis.

Optimal Hemodynamics

Produces a more laminar flow transition

Mechanical Support

Structurally reinforces the juxta-anastomotic segment

Retain Control Post-Surgery

Implanted during AVF creation surgery, VasQ retains the optimal configuration of the anastomosis during the critical weeks of maturation post-surgery and beyond.
Example of 3-month VasQ supported fistula

Venous Tapering

Smoothly transitions flow to the dilated fistula

Arterial Arch

Designed to guide arterial flow towards the vein

Create More Usable Fistulas​

In a recent randomized, controlled multi-center study3, more VasQ patients used their fistula for hemodialysis and could discontinue CVC use than patients treated without VasQ.
VasQ patients also had a lower incidence of stenosis or occlusion with consistent outward (dilative) remodelling leading to a greater mean diameter as compared to patients treated without VasQ.

 

The high AVF usability4 was associated with:

  • Greater freedom from >50% stenosis anywhere along the access vein (P=.04)
  • Consistent venous dilation above 6 mm for each patient that led to a greater mean diameter (P = .03)

Building Consistent Clinical Success with VasQ

86% - 100% AVF Usability4 at 6 months for multiple studies at a variety of clinics

FIM study
93% AVF Usability
20-pt prospective, single-center. Proof-of-Concept study in BCF Patients.



Chemla et al. J Vasc Access 2016; 17 (3): 243-248
More info >>
EXT study
100% AVF Usability
40-pt multi-center, randomized-controlled study demonstrating improvement over standard of care.

Karydis et al Am J Kidney Dis. 2020; 75(1): 45-53
More info >>
Real-World Validation
≥86% AVF Usability5
5 separate single-center retrospective analyses of their first consecutive +6 cases.

Multiple conference presentations. Data on file
Info upon request >>
RCF Analysis
86% AVF Usability
33-pt, single-center, retrospective RCF study with 17-pt historical control demonstrating improvement over standard of care.
Shahverdyan et al. J Vasc Access 2020 (online ahead of print)
More info >>
VALUE study
92% AVF Usability
80-pt RCF+BCF prospective multinational EU study.



Study on-going. Interim update Dec ’19. Data on file
Info upon request >>
US Pivotal study
Data not yet available6
144-pt RCF+BCF prospective, multi-center US study.




Study on-going
Info coming soon
1. Roy-Chaudhury P, Spergel LM, Besarab A, Asif A, Ravani P. Biology of arteriovenous fistula failure. J Nephrol 2007; 20: 150-163
2. VasQ is not available in the US. See the product availability for more information
3. Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M, Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized-Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53
4. AVF usability was defined as an AVF either used in dialysis or deemed usable for dialysis
5. Data based on follow-up periods that vary between 6 weeks and 1 year
6. Data not yet analyzed to be included in the usability range above

The VasQ Procedure

VasQTM creates a tapered juxta-anastomotic venous segment to promote a more laminar flow profile

Images used as an example of the intended result of the application of VasQ. Individual patient results may vary.
Henschtel and Bergner. A.A Computational Fluid Dynamics (CFD) Approach to Optimize Arterial-Venous Autogenous Access (AVF) Anastomotic Hemodynamics With an External Support Device (VasQ™). SN 2018. PO-720

VasQ™ is intended to relieve excessive mechanical stress of the unsupported juxta-anastomotic vein segment

Images are used as an example of the intended result of the application of VasQ. Individual patient results may vary.
1. Yang et al. Nature Scientific Reports 2017;7: 14298 | DOI:10.1038/s41598-017-14696-z

Create More Usable Fistulas​

Consistent Outward Remodeling with Greater Mean Diameters in the Cannulation Zone (P = .03)​

The graphs highlight the diameters measured for each patient's fistula in the cannulation zone and their trends over time. This data analysis is based on a 40 patient randomized controlled study of VasQ.

The majority of the VasQ patients experienced consistent venous dilation with each measuring >6 mm at the 6-month follow-up. For the control arm, a large proportion of patients experienced venous constriction to diameters <6 mm at the 6-month follow-up.
This is an additional analysis of the recently published VasQ study: Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M,
Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53

Minimize Stenosis and Occlusions​

Greater Freedom from ≥50% Stenosis or Occlusion with VasQTM External Support (P=.04)​


The graph shows Kaplan-Meier survival curves for patients freedom from observed stenosis >50% or occlusion anywhere along the access vein. This data analysis is based on a 40 patient randomized-controlled study of VasQ.

A significantly lower incidence of stenosis or occlusion was observed for VasQ patients as compared to the control group.

Karydis, Charing CX 2019. Data on file. This is an additional analysis of the recently published VasQ study: Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M,
Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53

VasQTM Real-World Validation with Initial Use Test Series

AVF Usability*
90%
86%
100%
100%
90%
Follow
1 Year
6 Weeks
6 Months
3-6 Months
10 Months
N
10
9
9
6
28
Presented
DGG 2017 Frankfurt
DGG 2018 Bonn
LINC 2018 Leipzig
DIVA 2018 Varese
DGG 2018 Bonn
*AVF usability was defined as an AVF either used in dialysis or deemed usable for dialysis
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