Vascular solutions company AngioDynamics has announced the U.S. FDA’s granting of a 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter. This comes alongside the news that its distribution partner, Medcomp Inc.’s, 510(k) application for the Celerity tip location system has been rejected by the agency. AngioDynamics will now take regulatory control over that product platform and is sounding positive about the prospects for an early resolution.
AngioDynamics says its BioFlo DuraMax chronic hemodialysis catheter is the first dialysis catheter with Endexo technology, creating a catheter material more resistant to the accumulations of blood components compared to non-coated conventional catheters. In vitro blood loop model test results show the catheter had 90% less thrombus accumulation on its surface on average compared to non-coated conventional catheters based on platelet count and 83% less thrombus accumulation on its surface compared to a heparin coated dialysis catheter. In addition, results of an in-vivo sheep study with 31-day indwell time, demonstrated comparable thromboresistance characteristics to a heparin coated dialysis catheter.
This is the third U.S. clearance of a BioFlo product line in the Company’s Vascular Access business. Indicated for use in attaining long-term vascular access for hemodialysis and apheresis, AngioDynamics expects a commercial launch in the fourth quarter of fiscal year 2014.
Now over to the Celerity line, hitherto submitted for FDA clearance by Medcomp, Inc. AngioDynamics has taken the view that the FDA’s decision not to clear the device resulted from the execution of a human factors study rather than the device itself, and following discussions with the Agency, believes it can fully address these issues in a subsequent filing, which it expects to be submitted in early April.
So the AngioDynamics folk have picked up the phone to Medcomp and executed an agreement that will see them acquire regulatory control over the Celerity platform and exclusive rights to a next generation system that includes navigation capabilities.
In the meantime, AngioDynamics continues to sell Celerity in Canada, where it says the market response to the combined offering of the system with the Company’s thromboresistant BioFlo PICC has been positive.
“Based on our review and discussions with the Agency, we have established a clear regulatory path to bring Celerity to the U.S. market by mid-summer,” said Joseph M. DeVivo, AngioDynamics’ President and Chief Executive Officer. “With this new agreement, we have established a clear plan to build a strong tip-location portfolio that includes next-generation product introductions.
“Our Vascular Access Business has been strengthening over the last several quarters with building clinical evidence of our BioFlo thrombus-resistant catheters,” DeVivo added. “With our fiscal third quarter closed last week, I am pleased to announce our U.S. Vascular Access Business has returned to growth for the first time since the acquisition of Navilyst, joining our already growing International Vascular Access Business. I am looking forward to the commercial introduction of Celerity in the U.S., which will only accelerate the positive momentum our business has.”
Source: AngioDynamics, Inc., Globe Newswire