Covidien’s Fortrex PTA Balloon receives FDA 510(k) clearance

The balloon facilitates Arteriovenous access in patients receiving hemodialysis

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The balloon provides physicians with a high pressure solution to crack the short, fibrous lesions

Covidien has announced that it has recieved the US 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. 

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

"Covidien is committed to being the clear first choice for physicians by delivering new, innovative technologies that help improve patient lives," said Mr Brian Verrier, president, vascular therapies, Covidien. He added, "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."

 

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