VENOS-3 Pivotal Study of the Velocity® Percutaneous Arteriovenous Fistula System:

General Information

VENOS-3 Pivotal Study of the Velocity® Percutaneous Arteriovenous Fistula System: General Information

Important VENOS-3 Study Information

  • If a patient has a wrist band with a QR code that links to this page, the patient is participating in the VENOS-3 Pivotal Study of the Velocity® System for dialysis vascular access.
  • If the patient requires thrombectomy or other dialysis access related intervention, please contact the relevant study site prior to intervening.
  • If the patient is being admitted to the hospital for any reason, please contact the relevant study site to inform them of the adverse event.

What is the Velocity® System?

  • The Velocity System uses a permanent implant to create an arteriovenous fistula which is a physical connection between an artery and an adjacent vein.
  • The implant is a 5 mm diameter x 23 mm long endoprosthesis that is implanted just below the elbow.
  • The implant is constructed with Expanded Polytetrafluoroethylene (ePTFE), a Nickel Titanium (NiTi) Alloy, and Fluorinated Ethylene Propylene (FEP).
  • The Velocity implant connects the cubital perforating vein to the proximal radial artery.
  • The fistula permits high pressure blood from the artery to flow into the vein. A mature vein enables repeated cannulation of the AVF for hemodialysis and provides adequate flow to support the dialysis circuit.
  • Visualization/Location: The implant is radiographically opaque and is visible with plain film x-ray and fluoroscopy. It is located approximately 2-3 cm distal to the elbow articulation.

Velocity® System Safety Information

The following interventions and procedures should be avoided in the arm with the Velocity System as they may negatively affect the performance of the fistula.

 

  • Blood pressure measurement
  • Phlebotomy in the veins near the cubital fossa
  • IV access

Velocity® System Cannulation Information

The arteriovenous fistula created by the Velocity System is designed to direct all fistula flow to the upper arm superficial veins. The intended vein for hemodialysis cannulation is the upper arm cephalic vein. In some cases, the patient may have had their median-cubital vein or basilic vein banded or ligated to direct all flow through the cephalic vein to support dialysis.

Important: Please contact the relevant VENOS-3 study site for additional information on the appropriate cannulation technique for patients enrolled in the study.

 

  • The AVF created by the Velocity System should be managed similar to a brachiocephalic AVF.
  • The preferred cannulation sites are in the upper arm cephalic vein. For initial cannulations, the study site will mark the cannulation zone with a marker.
  • The arterial needle should be placed antegrade (towards the venous return).
  • Skin preparation, needle size selection and cannulation technique are per local unit standard operating procedure and at the patient’s nephrologist direction.
  • It is okay to use tourniquets for cannulation, but make sure a thrill continues to be felt when the tourniquet is up. Make sure to release the tourniquet once the needle is secured.

Additional Information for the Velocity® System

Velocity System Instructions for Use (IFU)

 

Click here to view the Velocity System Instructions for Use (IFU)

Velocity System MRI Safety Information