FDA Clears AngioDynamics’ BioFlo DuraMax Chronic Hemodialysis Catheter

AngioDynamics has received FDA 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter, the Latham, N.Y.-based devicemaker said Friday.

BioFlo DuraMax is indicated for attaining long-term vascular access for hemodialysis and apheresis and is the first dialysis catheter with proprietary technology that makes it more resistant to accumulations of blood components as compared to non-coated catheters, the company said.

The cathether is inserted percutaneously into an adult’s internal jugular or subclavian veins for more than 30 days. It comes in nine different lengths to help reduce risk of arterial insufficiency.

This is the third U.S. clearance for a BioFlo product, AngioDynamics says. Its BioFlo peripherally inserted central catheters were cleared in August 2012, while the BioFlo Port was cleared in August 2013.

AngioDynamics plans to launch BioFlo DuraMax in the U.S. in the fourth quarter of 2014. — Lena Freund

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