LATHAM -- AngioDynamics announced Wednesday it has received government clearance to begin marketing and selling a medical device that brings a new level of safety to a range of medical procedures.
The Food and Drug Administration has given 510(k) clearance to AngioDynamics’ BioFlo peripherally inserted central catheters. The devices are used in many medical procedures, including chemotherapy, and are designed to remain in place for prolonged periods of time.
The BioFlo catheter is the first AngioDynamics product to use the company’s Endexo technology, which reduces the chance of occlusions — non-infectious blood clots — both on and inside the catheter. Such clotting can cause serious complications for patients.
With the Endexo technology, the clot-reducing material is blended into the polymer that makes up the catheter. Until now, clot-reducing tactics have included the use of drug coatings on the catheters’ walls or technologies that “impregnate” a clot-reducing material into the catheter material.
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The AngioDynamics technology “is present throughout the catheter shaft material and is not superficial or transient like coatings or impregnated materials,” according to an AngioDynamics statement. That results in a catheter that reduces clotting for the life of the catheter, without complications that can come from drug-coated devices, the company said.
“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.
He said AngioDynamics expects the new technology to help the firm grow its 15 percent share of the $375 million U.S. market for peripherally inserted central catheters.
AngioDynamics cited tests that showed BioFlo catheters had 87 percent less clotting on both the outside and inside of the device, compared with commonly used peripherally inserted central catheters. Tests also showed the BioFlo catheters were as effective as catheters coated with clot-reducing drugs, the company said.
With the FDA approval in hand, AngioDynamics expects to launch BioFlo catheters within 30 days, according to Chuck Greiner, vice president of AgnioDynamics’ 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,” Greiner said in a prepared statement. “Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters.”
BioFlo catheters and the Endexo technology came to AngioDynamics through the company’s recent acquisition of Navilyst Medical in May.
The BioFlo products are made at the Glens Falls facility, which was formerly owned by Navilyst. AngioDynamics also owns facilities in Queensbury.
Company officials could not be reached for comment Wednesday about what impact, if any, the new device will have on employment at the Glens Falls plant.