Covidien Unblocks AV Access Market with FDA Clearance of Fortrex™ PTA Balloon

Covidien plc has gained U.S. FDA 510(k) clearance for its Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.

Background

AV access sites are used to provide hemodialysis to patients. An occupational hazard for the medical professional however is the development of plaque blockages at the dialysis site.

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

The company tells us that the uniquely engineered device also provides clinicians with:

  1. 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.
  2. 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.
  3. 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 Fortrex™ 0.035” OTW PTA balloon catheter, termed by Covidien the “next-generation high pressure solution to maintain arteriovenous (AV) access,” is also intended for use in the peripheral vascular system.

Company comments

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

“Covidien is committed to being the clear first choice for physicians by delivering new, innovative technologies that help improve patient lives,” said Brian Verrier, president, Vascular Therapies, Covidien. “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.”

Source: Covidien, plc., Business Wire

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