FDA Clears Covidien Percutaneous Transluminal Angioplasty Balloon Catheter

Dublin, Ireland-based Covidien plc has received 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 inch 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.

“Access to the vessel must be properly maintained to help improve long-term use of hemodialysis,” said Mark Turco, M.D., chief medical officer, vascular therapies, Covidien. “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.”

In 2009, more than 398,000 patients in the United States were treated with some form of dialysis for end-stage renal failure. Hemodialysis, the most common type of dialysis, is a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy. AV access sites are used to provide hemodialysis to patients. However, plaque blockages at the dialysis site can limit access.

The Fortrex PTA balloon provides physicians with a high pressure solution to crack the short, fibrous lesions that can block AV access.

Medical technology company Covidien is in the process of being acquired by Medtronic Inc.