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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) <!–(popup)–>
  • Consistent venous dilation above 6 mm for each patient that led to a greater mean diameter (P = .03) <!–(popup)–>

Building Consistent Clinical Success with VasQ

visual

The VasQ Procedure

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

Untapered Configuration at the Optimized Angle

Standard AVF configurations typically result in large areas of disturbed flow near the anastomosis. The result is a region of low wall shear stress that leads to the development of neointimal hyperplasia in response.

VasQ Tapered Configuration

The tapering reduces the area of disturbed flow that contacts the vessel wall and pushes it away from the anastomosis. VasQ creates a 50% tapered diametric growth to smoothly transition flow to the vain.

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

During AVF creation, a vein segment is removed from the surrounding connective tissue that provides natural external support and mobilized to be sutured to the artery.

Excessive mechanical stress on the vein from the increase in transmural pressure due to higher flow volumes leads to
  • Increased cellular proliferation in the vessel wall1
  • Reduced lumen area from intimal thickening1

Reintroduces structural support to the mobilized section of vein.

External support has demonstrated in animal models to
  • Minimized cellular proliferation in the vessel wall1
  • Increased lumen area 1
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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