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November 25, 2014

FDA grants 510(k) clearance for Covidien’s Fortrex PTA balloon catheter

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Ireland-based Covidien's Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Ireland-based Covidien’s Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.

Fortrex 0.035in OTW PTA balloon catheter is the next-generation high-pressure solution to maintain arteriovenous (AV) access, and is also designed for use in the peripheral vascular system.

The company said the common procedure is to maintain AV access in patients receiving haemodialysis for chronic kidney disease or end-stage renal failure.

Covidien Vascular Therapies chief medical officer Dr Mark Turco said: "Access to the vessel must be properly maintained to help improve long-term use of haemodialysis.

"Fortrex 0.035in OTW PTA balloon catheter is the next-generation high-pressure solution to maintain arteriovenous (AV) access, and is also designed for use in the peripheral vascular system."

"The Fortrex PTA balloon has been engineered to maximise the inflation of the balloon to break up the blockages and open the vessel, providing better haemodialysis access."

The balloon catheter provides physicians a high-pressure solution to crack short and fibrous lesions that can block AV access.

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Covidien claims the catheter enables optimised balloon delivery and offers procedural efficiency, as well as helps targeted and predictable treatment.

Covidien vascular therapies president Brian Verrier said: "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 haemodialysis."

In 2009, more than 398,000 patients in the US were treated with some form of dialysis for end-stage renal failure.

Haemodialysis is the most common type of dialysis, a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy.

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