Fortrex™ PTA Balloon Facilitates Arteriovenous Access in
Patients Receiving Hemodialysis for Chronic Kidney Disease
DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 24, 2014--
Covidien plc (NYSE: COV) today announced 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” OTW PTA balloon catheter —the next-generation high
pressure solution to maintain arteriovenous (AV) access—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.
“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.”
In 2009, more than 398,000 patients in the U.S. were treated with some
form of dialysis for end-stage renal failure.1 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.
Furthermore, its unique 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
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
“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.”
Covidien is a global health care leader that understands the challenges
faced by providers and their patients and works to address them with
innovative medical technology solutions and patient care products.
Inspired by patients and caregivers, Covidien’s team of dedicated
professionals is privileged to help save and improve lives around the
world. With more than 39,000 employees, Covidien operates in 150-plus
countries and had 2014 revenue of $10.7 billion. To learn more about our
business visit www.covidien.com
or follow us on Twitter.
1 Kidney Disease Statistics for the United States. National
Kidney and Urologic Diseases Information Clearinghouse (NKUDIC). http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/
Source: Covidien plc
Krystin Hayward, 508-261-6512
Vice President, External Communications
Lannum, CFA, 508-452-4343