AngioDynamics has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its BioFlo DuraMax chronic haemodialysis catheter, designed for use in attaining long-term vascular access for haemodialysis and apheresis.
The BioFlo DuraMax chronic haemodialysis catheter is the third US clearance of a BioFlo product line in the company’s vascular access business.
It is the first dialysis catheter to incorporate Endexo technology, which creates a catheter material more resistant to the accumulations of blood components compared with non-coated conventional catheters.
The company expects to launch the BioFlo DuraMax chronic haemodialysis catheter in the fourth quarter of fiscal 2014.
AngioDynamics president and CEO Joseph DeVivo said BioFlo continues to be an solid platform for the 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 said.
The catheter showed 90% less thrombus accumulation on its surface on average compared to non-coated conventional catheters based on platelet count in an in vitro blood loop model test. It also had 83% less thrombus accumulation on its surface compared with a heparin coated dialysis catheter.
Similarly, the results from an in-vivo sheep study with 31-day indwell time, demonstrated comparable thromboresistance characteristics to a heparin coated dialysis catheter.
Global Vascular Access Franchise senior vice-president Chuck Greiner said AngioDynamics currently has a 15% share of the approximately $100m US chronic dialysis catheter market.
"Similar to the PICC and Port markets, we see growing interest in thromboresistance among nephrologists and dialysis centres due to the significant mortality rates DVT and PE present to this patient population," Greiner said.
"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."
According to GlobalData estimates, the dialysis catheters market in the US was valued at $850m in 2012 and is expected to grow at a CAGR of 0.7% to reach $1.3bn by 2019.
Image: AngioDynamics receives FDA clearance for DuraMax dialysis catheter with BioFlo technology. Photo: courtesy of Freedigitalphotos.net.