Technology | December 04, 2014

Covidien's Fortrex PTA Balloon Receives FDA Clearance

Fortrex PTA balloon facilitates arteriovenous access in patients receiving hemodialysis for chronic kidney disease

Balloon catheter, interventional radiology, FDA clearance, kidney disease

Image courtesy of Covidien

December 4, 2014 — Covidien announced that it 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 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.

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. The products engineering provides clinicians with:  

·       Optimized balloon delivery: Fortrex PTA balloon’s low tip entry profile and robust, flexible shaft design combine to enable tight tracking to the wire and successful navigation in tortuous vessels.

·       Predictable and targeted treatment: The balloon material and design permit shape retention at rated burst pressure, ensuring focused pressure on the lesion for controlled, targeted and predictable treatment.

·       Procedural efficiency: The combination of balloon material and wall thickness enables reliable balloon rewrap and reinsertion along with a top tier deflation time, all of which contribute to the efficiency of the procedure.

For more information: www.covidien.com

 

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