Implantation Procedure

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PRODUCT DESCRIPTION
The FLIXENE IFG (Intraluminal Flow Guard) is a uniquely engineered T-shaped vascular graft specifically designed as an upper arm A-V graft. This new concept, facilitates the insertion of a Nitinol reinforced intraluminal graft portion directly into the vein for a less abrupt flow transition. The IFG is designed to help improve flow dynamics by reducing arterialized pressure along the venous anastomotic junction.

IFG CONSTRUCTION
The FLIXENE IFG vascular graft is a composite graft, built from Atriums proprietary biomaterial lamination process with a reinforced Nitinol support section for intraluminal placement. The composite layers are designed to maximize handling, strength, improve implantation properties, and withstand repeated dialysis needle cannulation. The FLIXENE graft wall construction prevents and/or Incorporation zone Direction minimizes any 60 micron of blood ow weeping from Hydrostatic protection occurring membrane <5 micron following TOE HEEL portion portion implantation. Flow interface zone
60/20 micron

IFG Implantation Procedure

Isolate vein
Expose upper arm and antecubital fossa vessels Provide proper vein exposure (minimum of 5 cm) at venous end

Measure upper arm vein to verify size

If less than 4.5mm, pre-dilation is needed 5.5 mm is the minimum (if less than 5.5 mm, the IFG may not be suitable for implantation) 6.0 mm to 7.5 mm is ideal

Tie off branches

Bleeding can occur behind IFG segment

Notice location of valves

If a valve is present, divide the valve leaflets to facilitate graft placement

Measure length of venotomy

Make a venotomy approximately 2.5 cm long

Dilate the vein

Place stay sutures both laterally and medially along the venotomy Dilate the vein using progressive vessel dilators up to 6 mm, unless the vein is clearly large enough

Insert the TOE portion of the IFG directly in the vessel

Insert TOE end of IFG by flexing/bending the IFG segment The nitinol reinforcement has the capability to slightly flex This allows the IFG TOE segment to be easily inserted into the venotomy Check position location within the vessel to ensure uniform shape

Next, insert the HEEL portion of the reinforced IFG graft

Insert HEEL end of the IFG portion first into the venotomy, making sure the vein abuts the main graft body This will ensure that the IFG segment is inserted in a stable position

Secure reinforced IFG segment in place:

A venogram may be performed to verify outflow performance Place stay sutures into vein around the IFG segment Larger veins may require additional stay sutures to achieve hemostasis

Tunnel graft portion in place after IFG segment install

Tunnel graft after placing IFG segment Diagram shows correct direction of tunneling

Final steps
After tunneling, cut off the Slider GDS attachment and remove the sheath Insert a compliant balloon (5.0 mm) from the arterial end of graft Inflate balloon within the IFG segment to ensure there are no kinks in the segment Remove the balloon Clamp graft above the IFG segment with shodded clamps Complete the arterial anastomosis

Graft Monitoring
Due to the increased wall thickness of the FLIXENE IFG Graft, a thrill may be difficult to detect. A stethoscope may be needed to confirm patency at the anastomotic site.

Venogram
Example of a FLIXENE IFG placed into the axillary vein
FLIXENE IFG in the Axillary Vein
Image Courtesy of Dr. Charles Moomey

FLIXENE IFG Ordering Information

Technical Data
IFG Average Wall Thickness (WT) IFG Internal Diameter (ID) IFG Length Straight FLIXENE Graft Wall Thickness Tapered FLIXENE Graft Wall Thickness 0.38 mm 5 mm 4.5 cm 1 mm 0.94 mm

5 mm 5.0 cm

Ordering Information
Diameter Length Description Code #

4-7mm 4-7mm 6 mm 6 mm 4-7mm

35 cm 30 cm 30 cm 45 cm 45 cm

Graduated Wall Taper (GWT) with 5mm IFG w/ Slider GDS Graduated Wall Taper (GWT) with 5mm IFG w/ Slider GDS 5mm IFG w/ Slider GDS Graduated Wall (GW) with 5mm IFG w/ Slider GDS Graduated Wall Taper (GWT) with 5mm IFG w/ Slider GDS

25081 25098 25083 25086 25079

Additional sizes are pending

Please refer to our website www.atriummed.com for a complete listing of FLIXENE products.

www.atriummed.com
ATRIUM MEDICAL CORPORATION ATRIUM EUROPE B.V. ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.

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