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| Covidien's Fortrex percutaneous transluminal angioplasty balloon catheter--Courtesy of Covidien |
Medtronic ($MDT) announced the U.S. launch of its Fortrex balloon catheter, which performs angioplasty to physically disrupt blockages so that vessels can accept therapy via an arteriovenous access point.The device will be used on patients in need of hemodialysis who suffer from kidney failure and renal disease.
"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," said Dr. Brian Dunfee Holmes Regional Medical Center in Melbourne, FL, in a statement.
Medtronic says the device has a low tip entry profile and flexible shaft enabling high deliverability of the device to the lesion using a guidewire.
"Medtronic's growing PTA portfolio includes trusted, lesion specific solutions for peripheral vascular disease," said Brian Verrier, Medtronic vice president and general manager of the company's peripheral vascular unit, in a statement. "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."
Hemodialysis involves sending a patient's blood through an external filter known as a dialyzer. Doctors use AV fistulas and AV grafts to connect arteries to veins, the National Institutes of Health explains. However, blood clotting at the access point--typically the arm--can reduce blood flow, creating a need for angioplasty balloon catheters to fix the problem.
The device was developed by Covidien. It's the type of low-commercial-risk, surgical interventional tool that the Medtronic sought from the $50 billion acquisition of the formerly independent company.
Upon the Fortrex's FDA clearance in November, Covidien said that nearly 400,000 U.S. end-stage renal failure patients were treated with hemodialysis in 2009.
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