AngioDynamics Gains FDA Clearance; Takes Over Clearance Application for Medcomp

Latham, N.Y.-based AngioDynamics Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bioflo Duramax chronic hemodialysis catheter.

This marks the third U.S. clearance of a Bioflo product line in the company’s vascular access business. AngioDynamics expects a commercial launch in the fourth quarter of fiscal year 2014 for the device indicated for use in attaining long-term vascular access for hemodialysis and apheresis.

“BioFlo continues to be an exceptional platform for our vascular access products,” said President and CEO Joseph DeVivo. “With the addition of dialysis, our broad offering of vascular access products featuring advanced thromboresistant technology gives us a unique position in the marketplace.”

Thrombotic occlusions can occur within 24 hours and are prevalent in up to 40 percent of chronic dialysis patients. The 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 percent less thrombus accumulation on its surface on average compared to non-coated conventional catheters based on platelet count and 83 percent 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.

“AngioDynamics currently has a 15 percent share of the approximately $100 million U.S. chronic dialysis catheter market,” said Chuck Greiner, Senior Vice President of AngioDynamics’ global vascular access business. “Similar to the peripherally inserted central catheter (PICC) and port markets, we see growing interest in thromboresistance among nephrologists and dialysis centers due to the significant mortality rates deep vein thrombosis and pulmonary embolism present to this patient population. With the Bioflo Duramax dialysis catheter, we strengthen our position by offering customers a premium technology at a price that can help them meet a significant, everyday need.”

Takeover of Medcomp Premarket Notification Application

AngioDynamics is also taking over the 510(k) application submitted by its distribution partner Medcomp Inc. for its Celerity tip location system.

AngioDynamics officials believe that the FDA’s decision resulted from the execution of a human factors study rather than the device itself. Following discussions with the agency, AngioDynamics believes it can fully address these issues in a subsequent filing, which it expects to be submitted in early April.

As a result of these developments, AngioDynamics has made an agreement with Medcomp and Medcomp’s development partner to acquire regulatory control over the Celerity platform and exclusive rights to a next generation system that includes navigation capabilities.

“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 DeVivo. “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 United States, which will only accelerate the positive momentum our business has.”

AngioDynamics continues to sell Celerity in Canada, where the market response to the combined offering of the system with the thromboresistant Bioflo PICC has reportedly been positive.

“We remain committed to emulating our success in Canada, leveraging the Celerity tip location system to bolster our growing Bioflo PICC business in the United States,” Greiner. “With the amount of positive user data on Bioflo products growing, we are beginning to see an acceleration of hospital conversions and a renewed strength in our vascular access business. A key poster on Bioflo PICCs was presented in the quarter at the 2014 American Nurses Association Quality Conference, where the data from Bioflo once again confirmed significant clinical and economic results compared to the competition. In total, there are now more than 2,000 data points reporting similar findings. We are confident our new regulatory and development strategy for tip location will enable us to quickly bring Celerity to the U.S. market, as well as provide us with a competitive next-generation system that includes integrated EKG and navigation capabilities.”