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Covidien receives FDA 510(k) approval for PTA balloon catheter

Ireland-based Covidien has received 510(k) approval from the US Food and Drug Administration for its Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.

Athlone

The Fortrex 0.035OTW PTA balloon catheter has been developed to maintain arteriovenous (AV) access, as well as for use in the peripheral vascular system.

Covidien noted that the common procedure is to maintain AV access in patients receiving hemodialysis for chronic kidney disease or end stage renal failure.

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

"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."

The ballon catheter offers physicians a high pressure solution to crack the short and fibrous lesions that can block AV access.

According to Covidien, the catheter allows optimized balloon delivery and offers procedural efficiency, as well as helps in 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 hemodialysis."


Image: Covidien’s manufacturing facility in Athlone, Ireland . Photo: courtesy of Covidien plc.