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New Study Shows Addition of Stent Thrombectomy More Effective Than Traditional Pharmaceutical Treatment for Acute Ischemic Stroke Patients

DUBLIN, Ireland - Thursday, December 18th 2014 [ME


(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.


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 or follow us on Twitter.

Photos/Multimedia Gallery Available:



Vascular Therapies
David T. Young, 508-452-1644
Manager, External Communications


Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations


Peter Lucht, 508-452-4168

Vice President, External Communications
Corporate Communications


Todd Carpenter, 508-452-4363
Senior Director
Investor Relations



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