ILLUMENATE
First-in-Human Clinical Trial Supports the Stellarex™ Balloon with
EnduraCoat™ Technology in Treating Peripheral Arterial Disease
PARIS - Thursday, May 22nd 2014 [ME NewsWire]
(BUSINESS
WIRE)-- Covidien’s Stellarex™ drug-coated angioplasty balloon
(Stellarex DCB) continues to be shown as safe and effective for
treatment of peripheral arterial disease (PAD), according to new
24-month data released today from the company’s ILLUMENATE
First-in-Human (FIH) Study. The Stellarex DCB uses EnduraCoat™
technology, a durable, uniform balloon coating designed to prevent drug
loss during transit and facilitate controlled, efficient drug delivery
to the treatment site. The FIH study results were reported at the
EuroPCR Scientific Congress in Paris, held May 20-23, 2014.
According
to The Lancet, 40.5 million cases of PAD were reported in Europe in
20101. PAD is one of the most common vascular diseases and is associated
with heart attack, stroke, amputation and death. It occurs when
arteries in the legs become narrowed or blocked by plaque. These
blockages can result in severe pain, limited physical mobility and
non-healing leg ulcers.
The ILLUMENATE FIH study is a prospective,
multi-center, single arm study designed to assess the safety and
effectiveness of the Stellarex DCB. In the study, 58 superficial femoral
and/or popliteal lesions in 50 patients were pre-dilated with an
uncoated angioplasty balloon, followed by treatment with the Stellarex
DCB. When used to treat lesions in leg arteries, the Stellarex DCB is
intended to open narrowed or occluded vessels to restore blood flow and
simultaneously deliver paclitaxel, the drug used in the balloon coating,
to the vessel wall. This helps prevent restenosis, or the formation of
new blockages within an artery, after the artery has been treated.
The study found the Stellarex DCB to be safe, with durable results to 24 months, including:
Primary
patency (defined as the treated artery remaining open without further
treatment required or renewed blockage detected by ultrasound scanning)
was 82.3 percent at 24 months.
Freedom from clinically-driven target
lesion revascularization at 24 months was 87.9 percent. This is the same
rate observed at 12 months; no new events were reported demonstrating a
sustained low rate of repeat treatment out to 24 months.
No amputations or cardiovascular deaths were reported.
“We
are very pleased with the study’s promising results, as they support
the use of an important emerging treatment for a painful and physically
limiting condition that affects millions of people around the world,”
said Dr. Henrik Schröder, MD, Radiologist, Vascular Center-Jewish
Hospital, Berlin, Germany, and principal investigator, ILLUMENATE FIH
Study. “Good patency after two years, which translated into the absence
of new clinically-driven target lesion revascularizations after one year
and through the second year patient follow up, demonstrates the
durability of the Stellarex drug-coated angioplasty balloon.”
Covidien is conducting additional large clinical trials to further validate the FIH findings.
“ILLUMENATE’s
long-term results represent some of the best 24-month patency and
freedom from target lesion revascularization rates seen in
first-in-human studies to date. “These encouraging, long-term findings
suggest Stellarex may be uniquely effective compared with other
paclitaxel-based DCBs,” said Dr. Mark A. Turco, MD, chief medical
officer, Vascular, Covidien. “The ILLUMENATE trial series demonstrates
Covidien’s ongoing commitment to develop innovative solutions for
treating vascular diseases.”
About Covidien
Covidien is a leading
global healthcare products company that creates innovative medical
solutions for better patient outcomes and delivers value through
clinical leadership and excellence. Covidien develops, manufactures and
sells a diverse range of industry-leading medical device and supply
products. With 2013 revenue of $10.2 billion, Covidien has more than
38,000 employees worldwide in more than 70 countries, and its products
are sold in over 150 countries. Please visit www.covidien.com to learn
more about our business.
1 Fowkes, et al. “Comparison of Global
Estimates of Prevalence and Risk Factors for Peripheral Arterial Disease
in 2010: A Systematic Review and Analysis.” Lancet 2013 October
19:382(9901):1329-40.
Contacts
Covidien
David T. Young, 508-452-1644
Manager, External Communications
Vascular Therapies
david.young@covidien.com
Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
Peter Lucht, 508-452-4168
Vice President, External Communications
Corporate Communications
peter.lucht@covidien.com
Todd Carpenter, 508-452-4363
Senior Director
Vascular Therapies
todd.carpenter@covidien.com
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