Solving AVF Cannulation Challenges

7/25/2019 Solving AVF Cannulation Challenges

1/6

Solving AVFCannulation Challenges

VWINGVascular Needle Guide

and Guided Cannulation Technique


2/6


3/6

Safe. Consistent. Predictable Cannulation.

VWING Demonstrated ExcellentSafety and Efficacy in the U.S. SAVEProspective, 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

Dialysis in patients with an arteriovenous fistula (AVF) requires successful

cannulation, but safe, reliable, consistent cannulation can be very challenging.VWINGfrom Vital Access helps remove barriers to cannulation.

ctual Size

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

Funnel shape guides needle tospecific vessel entry point

Palpation ridge identifies exactneedle entry location

Provides separation betweenskin and vessel entry points a potential infection barrier3

Suture holes ensure properorientation and secure the device

Porous base promotes tissueingrowth Composed of commercially pure titanium

widely used in medical devices.

Direct AVF access no septum,door, or reservoir

Very Low Infection Rate*

AdverseEvents

Catheter(USRDS)

AV Fistula(USRDS)

VWING SAVEStudy Rate2

Infectionof access

1.45 0.18 0.038

Sepsis 2.32 0.52 0.038

* Per patient year


4/6

A Safe Alternative for EstablishingCannulatable 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.

Provides lower risk option to elevation or other

superficialization of deep vessels4

Offers a simple, less invasive alternative to basilic

vein transposition

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

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%)

Short segment 21 (39%)

Infiltrations 16 (30%)

Tortuous 6 (11%)

Aneurysm 3 (6%)

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

Implantation Is Easy and Minimally Invasive


5/6

Standardizes and Simplifies AVFCannulation to Reduce Catheter Time

VWING enables optimal vascular access for AVF patients,

potentially reducing dialysis catheter time1and its

associated risk of infection. VWING helps preserve

vascular access and establish cannulatable fistulas:

Standardizes cannulation even in small, poorly

defined, tortuous or unstable vessels

Helps revise failing AV fistula

Extends usable length in AVF with short

cannulatable segment

Minimizes vessel damage through guidedcannulation and reduced use of sharp needles

Facilitates self cannulation and aids home

hemodialysis

* FDA established a minimum clinical success rate of 37% for the SAVE trial,based upon current clinical success rates of elevation procedures reportedin the literature5

** Compared to 81% for fistula elevation procedures4

*** Compared to AVF sepsis rate of 0.52 per patient year according to theU.S. Renal Data System (USRDS, 2011)

**** All resolved during the course of the study

96% Cannulation Success of

Previously Uncannulatable AVF2

Endpoint Rate

3-Month Results

% of patients cannulated (n=51) 96%*

% of devices cannulated (n=79) 95%

6-Month Results

% of patients cannulated (n=47) 94%

% of devices cannulated (n=72) 92%

Secondary functional patency 100%**

Low Rate of Infection and Adverse Events

Systemic infection0.038 per

patient year***

Study related serious adverse events0.304 perpatient year****

Study related interventions0.65 perpatient year****


6/6

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.

1. Hill, A., Vasudevan, T., Young, N., Crawford, M., Blatter, D., Marsh, E., & ... Phillips, C. (2013). Use of an implantableneedle 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 WindowNeedle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. Journal OfVascular 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: Effectof 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. 00283 REVG

Ordering Information

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.

Size (hxw) Order #

4mm x 7mm 00153

6mm x 7mm 00144

8mm x 7mm 00145

10mm x 7mm 00146

Size (hxw) Order #

4mm x 9mm 00154

6mm x 9mm 00147

8mm x 9mm 00148

10mm x 9mm 00149

H

W

Vital Access Corporation448 E. Winchester St., Suite 250

Salt Lake City, UT 84107 USA

Phone: 801.433.9390

Fax: 801.433.9391

[email protected]

www.vital-access.com

Documents

Solving AVF Cannulation Challenges