EU CE Mark approval for BioFlo DuraMax chronic hemodialysis catheter

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AngioDynamics has announced it received EU CE Mark approval for its BioFlo DuraMax chronic hemodialysis catheter for use in attaining long-term vascular access for hemodialysis and apheresis. Thrombotic occlusions can occur within 24 hours and are prevalent in up to 40 percent of chronic dialysis patients. The BioFlo DuraMax chronic hemodialysis catheter is the first dialysis catheter with Endexo technology, creating a catheter material more resistant to the accumulations of blood components compared to non-coated conventional catheters.

In vitro blood loop model test results show the catheter had 90% less thrombus accumulation on its surface on average compared to non-coated conventional catheters based on platelet count and 83% less thrombus accumulation on its surface compared to a heparin coated dialysis catheter. In addition, results of an in-vivo sheep study with 31-day indwell time, demonstrated comparable thromboresistance characteristics to a heparin coated dialysis catheter.

“BioFlo continues to be an exceptional platform for our vascular access products,” said Joseph DeVivo, AngioDynamics’ President and CEO. “With the addition of dialysis, our broad offering of vascular access products featuring advanced thromboresistant technology gives us a unique position in the marketplace.”

“Similar to the PICC and Port markets, we see growing interest in thromboresistance among nephrologists and dialysis centers due to the significant mortality rates DVT and PE present to this patient population,” said Chuck Greiner, Senior Vice President of the Global Vascular Access Franchise. He added “With the BioFlo DuraMax dialysis catheter, we strengthen our position by offering customers a premium technology at a price that can help them meet a significant, everyday need.”

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