AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration has granted 510(k) clearance 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 U.S. 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.
“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% 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 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 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.”
*Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
Source: AngioDynamics.
