Covidien (NYSE:COV) said today that it won 510(k) clearance from the FDA for its Fortrex balloon catheter, which is designed both for maintaining arteriovenous access for hemodialysis and for treating peripheral artery disease.
Mansfield, Mass.-based Covidien said the Fortrex 0.035" over-the-wire device it "the next-generation high pressure solution to maintain arteriovenous access" and "is also intended for use in the peripheral vascular system."
"Access to the vessel must be properly maintained to help improve long-term use of hemodialysis," Dr. Mark Turco, vascular therapies chief medical officer said in prepared remarks. "The Fortrex PTA balloon has been engineered to maximize the inflation of the balloon to break up the blockages and open the vessel, providing better hemodialysis access."
"Covidien is committed to being the clear first choice for physicians by delivering new, innovative technologies that help improve patient lives," added vascular therapies president Brian Verrier. "The FDA clearance of the Fortrex PTA balloon builds on our existing PTA portfolio, providing clinicians with access to an advanced solution to improve AV access in patients being treated with hemodialysis."
Earlier this month, Covidien Covidien deal its Stellarex balloon to Spectranetics for $30 million as it seeks to mollify anti-trust regulators over its pending, $43 billion merger with Medtronic (NYSE:MDT).