Device Dossier

BioFlo™ DuraMax with Endexo Technology Chronic Hemodialysis Basic Kit, Single Valve - Catheter, haemodialysis, implantable

Device Dossier for BioFlo™ DuraMax with Endexo Technology Chronic Hemodialysis Basic Kit, Single Valve - Catheter, haemodialysis, implantable (Catheter,…

Intended purpose

The BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in adults. Catheters greater than 40 cm are intended for femoral vein insertion.

Functional description

The Basic Kit with Single Valve Sheath/Dilator is made from Carbothane with Endexo material. Endexo is shown to be effective in reducing thrombus accumulation (based on platelet count). The device may be inserted percutaneously, ideally placed in the jugular vein, although may be placed in the subclavian vein. Catheters greater than 40 cm are designed for femoral vein insertion. Device consists of the catheter, bifurcation, removable suture wing, cuff, extension legs, luers, and clamps.

TGA Public Summary