Albany, N.Y. – AngioDynamics officials announced the U.S. Food and Drug Administration granted 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter.
This marks the third U.S. clearance of a BioFlo product line in the company's vascular access business. Indicated for use in attaining long-term vascular access for hemodialysis and apheresis, AngioDynamics expects a commercial launch in the fourth quarter of fiscal year 2014.
"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."
Thrombotic occlusions can occur within 24 hours and are prevalent in up to 40% of chronic dialysis patients.1 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 count2 and 83% less thrombus accumulation on its surface compared to a heparin coated dialysis catheter.3 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 currently has a 15% share of the approximately $100 million U.S. chronic dialysis catheter market," said Chuck Greiner, senior vice president of the Global Vascular Access Franchise. "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. 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."
1 Whitman ED: Complications associated with the use of central venous access devices. Curr Probl Surg 33: 319-378, 1996
2 The reduction in thrombus accumulation (based on platelet count) is supported by acute in-vitro testing. Pre-clinical in-vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.
3 Based on benchtop testing performed up to two hours using bovine blood which may not be indicative of clinical results. Data on file.