ILLUMENATE First-in-Human Clinical Trial Supports the Stellarex™
Balloon with EnduraCoat™ Technology in Treating Peripheral Arterial
PARIS--(BUSINESS WIRE)--May 22, 2014--
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
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.”
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.
David T. Young, 508-452-1644
Lannum, CFA, 508-452-4343
Vice President, External Communications