Medtronic Rolls Out New Percutaneous Transluminal Angioplasty Balloon Catheter in U.S.

Dublin, Ireland-based Medtronic plc has introduced the Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter in the United States. This balloon catheter uses a high-pressure balloon to break up the blockages and open the vessels to help maintain arteriovenous (AV) access in the peripheral vascular system.

The device earned 510(k) clearance from the U.S. Food and Drug Administration last year.

“Being able to maintain AV access for patients receiving hemodialysis for renal disease and kidney failure is critical as it is a patient`s lifeline,” said Brian L. Dunfee, M.D., interventional radiologist at Holmes Regional Medical Center in Melbourne, Fla. “In the past, other high pressure balloons could lose their shape, making it challenging to focus the pressure on the lesion that was blocking the AV access. The Fortrex PTA balloon’s rated burst pressure provides me with a predictable and efficient solution to crack the short, fibrous lesions to restore AV access.”
 
The Fortrex PTA balloon can be used to maintain AV access in patients receiving hemodialysis for chronic kidney disease or end stage renal failure. In some cases, patients receiving hemodialysis will develop plaque blockages at the dialysis site, which can limit access. The Fortrex balloon’s material and design is meant to permit shape retention at rated burst pressure, ensuring focused pressure on the lesion for controlled, targeted and predictable treatment.

Additionally, the balloon has been engineered with a low tip entry profile and robust, flexible shaft to enable tight tracking to the wire and successful navigation in tortuous vessels. The balloon material and wall thickness are designed to enable reliable balloon rewrap and reinsertion. This, combined with its rapid deflation time, is hoped to improve efficiency of the procedure.

“Medtronic’s growing PTA portfolio includes trusted, lesion specific solutions for peripheral vascular disease,” said Brian Verrier, vice president and general manager of Peripheral Vascular, a business in Medtronic’s Aortic and Peripheral Vascular division. “We are excited to bring to market the Fortrex PTA balloon, which enhances our portfolio to provide clinicians with an innovative solution to improve AV access.”