AngioDynamics to Release Catheter with New Polymer Technology

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics’ BioFlo peripherally inserted central catheters (PICCs) with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter. 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 percent less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, the company claims, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter—although in vivo and in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation. According to AngioDynamics, this will be the first catheter available with pressure activated safety valve (PASV) valve technology that combines all of these properties with AngioDynamics’ valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

“BioFlo technology provides AngioDynamics with a truly disruptive technology which we believe will drive increased demand for our vascular access products,” said Joseph DeVivo, president and CEO of
AngioDynamics. “With 15 percent of the $375 million U.S. PICC market, AngioDynamics holds a strong second position and BioFlo technology is positioned to help us grow that presence. 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.”

A PICC is intended to allow intravenous access for an extended period for chemotherapy, antibiotic delivery and other intravascular therapies. Endexo, a permanent and non-eluting integral polymer, 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 U.S. 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 U.S. market. Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters.”

AngioDynamics is an Albany, N.Y.-based provider of minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology.