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Solving AVF

Cannulation Challenges
VWING Vascular Needle Guide
and Guided Cannulation Technique

VWING Guided Cannulation Technique:


A Revolution in Constant Site Cannulation
Provides a Safe, Consistent and Predictable Path to the Fistula
Constant site cannulation using blunt needles has been advocated as a means to overcome
the damaging effects of sharp needle cannulation experienced in rope ladder and area puncture
cannulation techniques.
Until now, buttonhole cannulation using a freehand technique was the only way to create
a constant site. Buttonhole, however, has many limitations: it is unguided, relies heavily on
the cannulators skill set and the patients anatomy, and is affected by shifting arm and fistula
positions from one dialysis session to the next. Because there are no means to ensure a single
cannulation path, multiple vessel puncture sites, increased trauma to the skin insertion point
and other complications may result, leading to an increased risk of infection and aneurysm.
VWINGs unique design enables a new way of performing constant site cannulation:
Palpation ridge indicates the fistula location and optimal skin insertion point
Funnel shape guides the needle to a consistent vessel entry point
Encapsulation by granulation tissue facilitates formation of a consistent tissue
path between skin and vessel
Provides separation between skin and vessel entry points a potential infection barrier3
Systemic infection rate was .038 per patient year in the U.S. SAVE Study2
VWING Guided Cannulation Technique standardizes the cannulation path and guides the
needle to a single vessel entry point to ensure safe, consistent and predictable access.

Advantages of VWING Versus Buttonhole Technique


Freehand Buttonhole Technique

Buttonhole cannulation may create multiple


paths from the skin to the fistula, resulting in
the formation of multiple vessel puncture sites.
Prolonged reliance on sharp needles and other
complications can damage the fistula and cause
trauma to the skin and subcutaneous tissue,
increasing risk of infection and aneurysm.

VWING Guided Cannulation Technique

VWING accurately guides the needle to a


consistent vessel entry point, standardizing
a path, enabling conversion to blunt needles in
as few as 2-3 cannulations, and thus minimizing
trauma to the fistula.

Safe. Consistent. Predictable Cannulation.


Dialysis in patients with an arteriovenous fistula (AVF) requires successful
cannulation, but safe, reliable, consistent cannulation can be very challenging.
VWING from Vital Access helps remove barriers to cannulation.
Provides easy subcutaneous target and guide for
a wide variety of anatomies, including deep AVF
Enables innovative Guided Cannulation Technique
that is safe, consistent and easy to learn
Offers a lower risk, minimally invasive alternative
to elevation and transposition procedures
Potentially reduces dialysis catheter time1
Facilitates transition to blunt needles to minimize
vessel damage

VWING Demonstrated Excellent


Safety and Efficacy in the U.S. SAVE
Prospective, Multi-Center Clinical Study2
96% success of primary endpoint (cannulation of
previously uncannulatable AVF)
100% secondary functional fistula patency at 6 months
Systemic infection was 0.038 per patient year

Very Low Infection Rate*


Adverse
Events

Catheter
(USRDS)

AV Fistula
(USRDS)

VWING SAVE
Study Rate2

Infection
of access

1.45

0.18

0.038

Sepsis

2.32

0.52

0.038

* Per patient year

Palpation ridge identifies exact


needle entry location

Funnel shape guides needle to


specific vessel entry point

Provides separation between


skin and vessel entry points
a potential infection barrier3

Direct AVF access no septum,


door, or reservoir

Suture holes ensure proper


orientation and secure the device

Actual Size
Porous base promotes tissue
ingrowth

Composed of commercially pure titanium,


widely used in medical devices.

A Safe Alternative for Establishing


Cannulatable Fistulas
Revising a fistula to improve cannulatability can be
challenging for vascular surgeons and poses risks for
patients. VWING provides a simple alternative, and may
be the best option to revise uncannulatable fistulas.

In SAVE Study, VWING Enabled Access to a Variety


of Previously Uncannulatable Fistulas2
Inclusion Criteria

Number of Fistulas (%) (n=54)

Not palpable

37 (69%)

3 failed access attempts

23 (43%)

Deep (>6mm)

23 (43%)

Provides lower risk option to elevation or other


superficialization of deep vessels4

Short segment

21 (39%)

Infiltrations

16 (30%)

Offers a simple, less invasive alternative to basilic


vein transposition

Tortuous

6 (11%)

Aneurysm

3 (6%)

Extends the usable length of AVF with short


cannulatable segment
Helps salvage AVF with aneurysm or damage
by easily creating a new cannulation location
May provide an alternative to an AV graft

Implantation Is Easy and Minimally Invasive


The single piece titanium VWING is easily implanted subcutaneously
Small incision of approximately 4 centimeters
Secured to the exterior wall of the fistula through suture holes
Implant procedure is efficient and predictable (typically < 30 minutes)
Usually performed with local anesthesia and conscious sedation
Ready for cannulation as early as 3 weeks after surgery
Expose the Vessel

Suture VWING to the Vessel

Close the Incision

Standardizes and Simplifies AVF


Cannulation to Reduce Catheter Time
VWING enables optimal vascular access for AVF patients,
potentially reducing dialysis catheter time1 and its
associated risk of infection. VWING helps preserve
vascular access and establish cannulatable fistulas:

96% Cannulation Success of


Previously Uncannulatable AVF2
Endpoint

Rate

3-Month Results
% of patients cannulated (n=51)

96%*

Standardizes cannulation even in small, poorly


defined, tortuous or unstable vessels

% of devices cannulated (n=79)

95%

Helps revise failing AV fistula

% of patients cannulated (n=47)

94%

Extends usable length in AVF with short


cannulatable segment

% of devices cannulated (n=72)

92%

Secondary functional patency

100%**

Minimizes vessel damage through guided


cannulation and reduced use of sharp needles
Facilitates self cannulation and aids home
hemodialysis

6-Month Results

Low Rate of Infection and Adverse Events


Systemic infection

0.038 per
patient year***

Study related serious adverse events

0.304 per
patient year****

Study related interventions

0.65 per
patient year****

* FDA established a minimum clinical success rate of 37% for the SAVE trial,
based upon current clinical success rates of elevation procedures reported
in the literature5
** Compared to 81% for fistula elevation procedures4
*** Compared to AVF sepsis rate of 0.52 per patient year according to the
U.S. Renal Data System (USRDS, 2011)
**** All resolved during the course of the study

Vital Access Corporation


448 E. Winchester St., Suite 250
Salt Lake City, UT 84107 USA
Phone: 801.433.9390
Fax: 801.433.9391
info@vital-access.com
www.vital-access.com

About Vital Access


Vital Access Corporation
is a privately held company
located in Salt Lake City
that designs and manufactures
surgical and interventional
technologies to improve
vascular access for patients
and caregivers. The VWING
Vascular Needle Guide is
commercially available in
the U.S., Europe, Canada,
and New Zealand.

Ordering Information

Size (hxw)

Order #

Size (hxw)

Order #

4mm x 7mm

00153

4mm x 9mm

00154

6mm x 7mm

00144

6mm x 9mm

00147

8mm x 7mm

00145

8mm x 9mm

00148

10mm x 7mm

00146

10mm x 9mm

00149

Before use, physicians should review all information


available within the Instructions for Use.
For a list of distributors, visit www.vital-access.com
or call 801.433.9390.

1. Hill, A., Vasudevan, T., Young, N., Crawford, M., Blatter, D., Marsh, E., & ... Phillips, C. (2013). Use of an implantable
needle guide to access difficult or impossible to cannulate arteriovenous fistulae using the buttonhole technique.
Journal Of Vascular Access, 14(2), 164-169. doi: 10.5301/jva.5000152
2. Jennings, W., Galt, S., Shenoy, S., Wang, S., Ladenheim, E., Glickman, M., & ... Brown, B. (2014). The Venous Window
Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. Journal Of
Vascular Surgery, 2014 May 13. doi: 10.1016/j.jvs.2014.04.016.
3. Wilson, N., & Shenoy, S. (2014). Managing buttonhole complications. The Journal Of Vascular Access, 15, S91-S95.
doi:10.5301/jva.5000247
4. Bronder, C., Cull, D., Kuper, S., Carsten, C., Kalbaugh, C., Cass, A., & ... Taylor, S. (2008). Fistula elevation procedure:
Experience with 295 consecutive cases during a 7-years period. Journal Of The American College Of Surgeons,
206(5), 1076-1081. doi: 10.1016/j.jamcollsurg.2007.12.030
5. Singh, P., Robbin, M., Lockhart, M., & Allon, M. (2008). Clinically immature arteriovenous hemodialysis fistulas: Effect
of US on salvage. Radiology, 246(1), 299-305. doi: 10.1148/radiol.2463061942
The VWING Vascular Needle Guide is manufactured under one or more of the following U.S. patent numbers:
8,337,464 and 8,337,465. Other U.S. and foreign patents pending.
2015 Vital Access Corporation. Vital Access is a registered trademark of Vital Access Corporation.

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