AngioDynamics Earns FDA Clearance for BioFlo PICC

August 29, 2012—AngioDynamics, Inc. (Latham, NY) announced that the US Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs). The device's Endexo technology is designed to reduce the accumulation of catheter-related thrombus on and in the catheter to provide intravenous access for an extended period for chemotherapy, antibiotic delivery, and other intravascular therapies, according to the company. An initial market launch is expected in the company's second quarter of fiscal year 2013. These products also have received CE Mark approval for Europe and are approved in Canada and other international markets.

According to AngioDynamics' press release, in vitro blood loop model test results show that 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. The BioFlo PICCs are available with PASV valve technology. AngioDynamics stated that its valve is designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

The company noted that the BioFlo PICC is manufactured with Endexo technology (Interface Biologics, Inc., Toronto, ON, Canada), which is a permanent and noneluting integral polymer. Endexo is blended into the catheter shaft's polymer, creating a material that provides long-term durability. The material is present throughout the catheter shaft material and is not superficial or transient like coatings or impregnated materials. The BioFlo PICC does not contain antibiotics or antimicrobials, agents that are potentially associated with bacterial resistance, AngioDynamics stated.