DUBLIN, Ireland - Thursday, December 18th 2014 [ME
NewsWire]
(BUSINESS WIRE)-- In a landmark study evaluating the
addition of stent thrombectomy clot removal to
pharmaceutical treatment for patients suffering an acute
ischemic stroke (AIS), stent thrombectomy provided a
significant clinical benefit when compared to pharmaceutical
treatment alone. Results from the Multi center Randomized
Clinical trial of Endovascular treatment for Acute ischemic
stroke in the Netherlands (MR CLEAN) have been
published online and will appear in the January 1 issue of
The New England Journal of Medicine ("NEJM"). Findings
were also presented at the World Stroke Congress,
confirming the effectiveness of stent thrombectomy.
The MR CLEAN study evaluated 500 patients suffering
from moderate to severe strokes and demonstrated that the
addition of stent thrombectomy during early treatment
doubled the likelihood of a good neurological outcome. The
study also confirmed that there was no increased safety risk
with the addition of the procedure.
“The results of MR CLEAN demonstrate that the addition
of stent thrombectomy to current pharmaceutical treatment
provides a significant clinical benefit to patients,” said
Professor Diederik Dippel, Erasmus Medical Center,
Rotterdam. “However, there is much work yet to be done
in the fight against this devastating disease, and we would
welcome confirmation of our findings in additional
randomized studies.”
One of the stent thrombectomy technologies studied in MR
CLEAN was the Solitaire™ device developed by Covidien
plc. The Solitaire device thrombectomy procedure uses a
micro sized catheter to access arteries in the brain affected
by stroke through an incision in the leg. Once delivered, the
Solitaire device helps to immediately restore blood flow and
remove the blood clots causing the stroke. The results of
the MR CLEAN study confirm results observed from
earlier stage Solitaire device stent thrombectomy studies
Solitaire With the Intention for Thrombectomy (SWIFT)
and Solitaire™ FR Thrombectomy for Acute
Revascularization (STAR).
Covidien currently supports a number of clinical studies that
are further investigating the addition of stent thrombectomy
to traditional pharmaceutical treatment for AIS. Data from
the Solitaire FR as Primary Treatment for Acute Ischemic
Stroke (SWIFT PRIME), Endovascular Treatment for
Small Core and Proximal Occlusion Ischemic Stroke
(ESCAPE) and Endovascular Revascularization With
Solitaire Device Versus Best Medical Therapy in Anterior
Circulation Stroke Within 8 Hours (REVASCAT) studies
will be presented in early 2015.
“We continue to support the clinical evaluation of this
breakthrough technology through several additional
randomized controlled clinical trials like SWIFT PRIME,
ESCAPE and REVASCAT that will look to confirm and
validate the MR CLEAN results,” said Brett Wall,
president, Neurovascular, Covidien. “We remain committed
to furthering the body of clinical evidence that drives best
medical practice and improved patient outcomes, and we
believe that the MR CLEAN study suggests that stent
thrombectomy is an important treatment option that should
be made available to patients suffering from moderate to
severe stroke.”
According to the World Heart Federation, of the 15 million
people who experience a stroke worldwide each year,
nearly six million die and another five million are left
permanently disabled. For patients who miss the 0-3 hour
window for treatment with pharmaceutical treatment such as
tissue plasminogen activator (tPA) or for those patients with
large vessel occlusion for which tPA has very limited
efficacy, additional therapy such as stent thrombectomy may
be the only treatment option.
ABOUT COVIDIEN
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.
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Contacts
Vascular Therapies
David T. Young, 508-452-1644
Manager, External Communications
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
Investor Relations
todd.carpenter@covidien.com
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