FDA Clears AngioDynamics' BioFlo Port Device for Reduction of Catheter-Related Thrombus

August 20, 2013—AngioDynamics, Inc. (Latham, NY) announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to Navilyst Medical Inc. (Marlborough, MA) for the BioFlo port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on and in the port catheter. An initial launch is expected in the third fiscal quarter of 2014.

AngioDynamics acquired Navilyst in 2012 from private equity firm Avista Capital Partners (New York, NY), which acquired Navilyst from Boston Scientific Corporation (Natick, MA) in 2008.

According to AngioDynamics, the BioFlo port's Endexo technology is a permanent and non-eluting integral polymer, designed to provide more resistance to the accumulation of platelets and thrombus. The BioFlo port is also available with the company's PASV valve technology, which is designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

According to AngioDynamics, BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics, 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 (based on platelet count).

AngioDynamics' BioFlo peripherally inserted central catheters with Endexo technology received FDA clearance in August 2012. The company noted that it expects to seek FDA clearance for BioFlo dialysis catheters in the future.