FDA Clears First Vascular Access Product With BioFlo Technology To Reduce Catheter-Related Thrombus

In short

Vascular access device company, AngioDynamics Inc., has announced the U.S. FDA has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology which the company says is 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.

Background

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 the company points out that are potentially associated with bacterial resistance.

AngioDynamics’ 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 to a heparin-coated vascular access catheter, although the company points out the fact that pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Available with PASV Valve Technology, BioFlo 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.

Company comments

“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.”

“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.”

Regulatory status

BioFlo products are currently CE marked for Europe and are approved in Canada and other international markets where they will compete with Teleflex’s Nylus™ Peripherally Inserted Central Catheter (PICC) with Semprus Sustain™ technology, another attempt to use an integrated polymer to reduce attachments of protein and other blood products to the catheter surface, covered on our pages here.

Source: AngioDynamics, Inc., Globe Newswire

Note: AngioDynamics, the AngioDynamics logo, BioFlo and PASV are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Endexo is a trademark of Interface Biologics.