AngioDynamics has obtained the 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter from the US Food and Drug Administration (FDA).
The BioFlo DuraMax chronic hemodialysis catheter is designed for use in attaining long-term vascular access for hemodialysis and apheresis. It is the third US clearance of a BioFlo product line in the company’s vascular access business.
It is the first dialysis catheter composed of Endexo technology, which creates a catheter material more resistant to the accumulations of blood components compared to non-coated conventional catheters.
According to AngioDynamics, 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, while 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.
AngioDynamics anticipates a commercial launch in the fourth quarter of fiscal year 2014.
AngioDynamics president and CEO Joseph DeVivo said BioFlo continues to be an exceptional platform for company’s vascular access products.
"With the addition of dialysis, our broad offering of vascular access products featuring advanced thromboresistant technology gives us a unique position in the marketplace," DeVivo added.