Clearance, an AngioDynamics company, has received the US Food and Drug Administration (FDA) 510(k) clearance for its BioFlo Port with Endexo technology, Clearance to the accumulation of platelets and thrombus.
The BioFlo Port is a permanent and non-eluting integral polymer and claimed to be the only port manufactured with Endexo technology.
Implantable ports are used to inject medications or other intravenous fluids such as chemotherapy, blood transfusions or delivery of total parenteral nutrition.
AngioDynamics president and CEO Joseph M DeVivo noted the company is pleased to build on the success of our BioFlo PICC by introducing the first port with a demonstrated reduction in thrombus accumulation.
"The introduction of BioFlo ports is consistent with our plan to bring disruptive technologies into the Vascular Access space and reflects the strengthening of our BioFlo platform," DeVivo added.
BioFlo technology has shown to be effective in reducing thrombus accumulation. The reduction in thrombus accumulation was evaluated using in-vitro blood loop models.
In-vitro blood loop model test results found that on average the BioFlo Port catheter had 96% less thrombus accumulation on its surface compared to commonly used non-coated port catheters.
The BioFlo ports are also available with AngioDynamics's owned PASV valve technology, designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.
The company expects to launch the product in the third quarter of fiscal year 2014.