Covidien Gets FDA OK for Balloon Catheter Used in Hemodialysis

Irish devicemaker Covidien said Tuesday that it has received FDA clearance for its Fortrex over-the-wire percutaneous transluminal angioplasty balloon catheter. The device is designed to maintain arteriovenous access in patients undergoing hemodialysis, as well as for use in the peripheral vascular system.

In hemodialysis, Fortrex gives physicians a high-pressure solution for cracking the short, fibrous lesions that can block AV access, the company says. Properly maintaining AV access helps the long-term use of hemodialysis, explains Mark Turco, chief medical officer for Covidien’s Vascular Therapies division.

The catheter’s low tip entry profile and flexible shaft design allow for tight tracking to the wire and successful navigation in vessels, while the balloon features a top-tier deflation time, which contributes to the efficiency of the procedure, the company says.

In 2009, more than 398,000 patients in the U.S. were treated with some form of dialysis for end-stage renal failure, according to Covidien. — Kellen Owings

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