The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics 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 US 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.
A PICC allows intravenous access for an extended period for chemotherapy, antibiotic delivery and other intravascular therapies. The BioFlo PICC is the only PICC manufactured with Endexo technology, a permanent and non-eluting integral polymer. Endexo is blended into the catheter shaft’s polymer, creating a material that provides long-term durability. It 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 potentially associated with bacterial resistance.
“We expect to launch BioFlo technology with PASV PICCs in the US within the next 30 days,” said Chuck Greiner, vice president of the Global Vascular Access Franchise. “Given the early success we have seen during our first market launch in Canada, we are excited to replicate the rapid adoption in the US market. Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters.”