AngioDynamics Inc Earns FDA Clearance For First Vascular Access Product With BioFlo Technology To Reduce Catheter-related Thrombus

AngioDynamics Inc announced the U.S. Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter. These are the first vascular access products from AngioDynamics to offer BioFlo technology in the U.S. market and an initial launch is expected in the Company's second quarter of fiscal year 2013. These products are currently CE marked for Europe and are approved in Canada and other international markets. In vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.* Available with PASV Valve Technology, it is the first catheter that combines all of these properties with AngioDynamics' patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.