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Covidien’s Fortrex™ PTA Balloon Receives FDA 510(k) Clearance

DUBLIN, Ireland--(BUSINESS WIRE)--Covidien plc (NYSE: COV) today announced U.S. Food and Drug Administration 510(k) clearance for its Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex™ 0.035” OTW PTA balloon catheter —the next-generation high pressure solution to maintain arteriovenous (AV) access—is also intended for use in the peripheral vascular system. A common procedure is to maintain AV access in patients receiving hemodialysis for chronic kidney disease or end stage renal failure.