The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics’ BioFlo peripherally inserted central catheters (PICCs), designed to reduce the accumulation of catheter-related thrombus.
The BioFlo PICC utilises Endexo, a permanent and non-eluting integral polymer, which is blended with the catheter shaft’s polymer to provide long-term durability.
It also utilises PASV Valve technology, which is designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.
BioFlo allows intravenous access for an extended period for chemotherapy, antibiotic delivery and other intravascular therapies, according to the company.
In vitro blood loop model test results demonstrated that BioFlo has on average 87% less thrombus accumulation on its surface compared to commonly used PICCs.
AngioDynamics president and CEO Joseph DeVivo said; "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."
AngioDynamics global vascular access franchise vice president Chuck Greiner said the company expects to launch the product in the US within the next month.
"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," Greiner said
"Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters."