AngioDynamics Gets FDA Approval For BioFlo Port With Endexo Technology

(RTTNews) - The U.S. Food and Drug Administration has granted 510(k) clearance to Navilyst Medical Inc., an AngioDynamics (ANGO) company, for its BioFlo Port with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter. This marks the second U.S. clearance of a product line developed with BioFlo's advanced technology; an initial launch is likely to occur in the third quarter of fiscal 2014.

The BioFlo Port is the only port manufactured with Endexo technology, a permanent and non-eluting integral polymer, designed to provide more resistance to the accumulation of platelets and thrombus.

BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics or antimicrobials, or any other transient materials typically associated with coated or impregnated technologies. In-vitro blood loop model test results show that on average the BioFlo Port catheter had 96% less thrombus accumulation on its surface compared to non-coated conventional port catheters.

Chuck Greiner, Vice President of the Global Vascular Access Franchise stated, "Given the strong performance we continue to see in BioFlo PICCs since our worldwide launch, we are excited to expand this premium technology into other segments. We will continue to grow our BioFlo vascular access portfolio by seeking FDA clearance for BioFlo dialysis catheters."