Covidien Fortrex PTA balloon gains 510(k)


Covidien has announced US Food and Drug Administration 510(k) clearance for its Fortrex 0.035” over-the-wire percutaneous transluminal angioplasty (PTA) balloon catheter. The next-generation high pressure solution to maintain arteriovenous access is also intended for use in the peripheral vascular system. A common procedure is to maintain arteriovenous access in patients receiving haemodialysis for chronic kidney disease or end stage renal failure.

 “Access to the vessel must be properly maintained to help improve long-term use of haemodialysis,” comments Mark Turco, chief medical officer, Vascular Therapies, Covidien. “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.”

In 2009, more than 398,000 patients in the USA were treated with some form of dialysis for end-stage renal failure. Haemodialysis, 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. Arteriovenous access sites are used to provide haemodialysis 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 arteriovenous access. Furthermore, its engineering provides clinicians with:

  •          Optimised 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.

“The FDA clearance of the Fortrex PTA balloon builds on our existing PTA portfolio, providing clinicians with access to an advanced solution to improve arteriovenous access in patients being treated with haemodialysis,” says Brian Verrier, president, Vascular Therapies, Covidien.