INSTRUCTIONS FOR USE
Sterile (EO) – For Single Use Only
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
(or properly licensed practitioner).
Description
The Vectra Vascular Access Graft (VAG) is composed of Thoralon
of segmented polyetherurethaneurea and a siloxane containing surface-modifying
additive (SMA). The grafts are available in two diameters, 5.0mm or 6.0mm, each with
a wall thickness of approximately 1.0mm.
The Vectra VAG features a self-bonded tri-layer design of Thoralon. (Figure 1)
• The microporous, blood-contacting inner layer contains an SMA rich environment
designed to minimize platelet adhesion.
• The solid middle layer prevents any communicating pathway between the inner and
outer layers, and gives the graft its strength, flexibility, and self-sealing properties.
• The microporous outer layer is designed to promote tissue ingrowth for enhanced
graft anchoring, and is reinforced for kink resistance with two thin monofilament
polyester fibers. Each reinforcement monofilament is wound circumferentially in
graduated concentrations along the length of the graft, with an unreinforced area at
either end. The concentration of the wraps increases from 10-12 wraps per inch
(W.P.I.) or 4-5 wraps per centimeter (W.P.C.) at either end of the graft to 24-32 W.P.I.
or 9.5-12.5 W.P.C. in the mid-portion of the graft for added kink resistance in the
apex when used in a loop configuration. (Figure 2)
Indications for Use
The Vectra VAG is indicated for use as a subcutaneous arteriovenous conduit for
blood access.
Contraindications
None.
Figure 1. Cutaway view of Vectra VAG
Figure 2. Vectra graft design (40cm pictured)
1
®
Vectra
Vascular Access Graft
®
, a proprietary blend
Microporous
Outer Layer
Self Sealing
Middle Layer
Microporous
Inner Layer