endovascular.es

Título: AngioDynamics Receives FDA Clearance for DuraMax Dialysis Catheter With BioFlo Technology to Reduce Catheter-Related Thrombus
Fecha: 07-03-2014
ALBANY, N.Y., March 7, 2014 (GLOBE NEWSWIRE) -- AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today 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 percent 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 percent 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.'
Fuente: endovascular.es

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