effectiveness
COLORADO SPRINGS, Colo., Jul 27, 2011 (BUSINESS WIRE) —
Covidien (NYSE:COV), a leading global provider of healthcare
products, today announced the results of the PUFS (Pipeline for Uncoilable or Failed AneurysmS) clinical study at the Society of
NeuroInterventional Surgery 8th Annual Meeting here.
PUFS is a single-arm, 108-patient study of large and giant,
wide-neck aneurysms or fusiform typically not coilable, with
positive six-month safety and effectiveness endpoints. The
Pipeline(R) Embolization Device, the first product in a
new class, received Premarket Approval in April 2011 and is
indicated for the endovascular treatment of adults (22 years of age
or older) with large or giant wide-necked intracranial aneurysms in
the internal carotid artery from the petrous to the superior
hypophyseal segments.
In summary, the Pipeline Embolization Device met the trial
primary endpoints for both effectiveness and safety. The efficacy
endpoint was pre-determined to be a success if the results were
statistically greater than 50% compared to actual results of 73.6%
(p-value <.0001). Efficacy was defined as complete aneurysms
occlusion at 180 days without major parent vessel stenosis and
without the use of other treatments. The safety endpoint was
pre-determined to be a success if the results were statistically
less than 20% compared to actual results of 5.6% (p-value
<.0001). Safety was defined as major ipsilateral stroke or
neurologic death at 180 days.
“The Pipeline Device redefines the treatment of uncoilable and
failed aneurysms,” said Joe Woody, President, Vascular Therapies,
Covidien. “The positive results of the PUFS trial further validate
the safety and efficacy of this device for patients.”
The Pipeline Embolization Device consists of two main mechanisms
of action: flow diversion, in which the Pipeline Device disrupts
the flow of blood from the parent artery into the aneurysm, and
re-endothelialization, where the Pipeline Device forms a scaffold
upon which endothelial cells can grow. Full coverage of the implant
with endothelial cells, including over the neck of the intracranial
aneurysm, seals the aneurysm fundus from the parent artery,
minimizing the risk of rupture, as well as recanalization.
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 manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4
billion, Covidien has 41,000 employees worldwide in more than 65
countries, and its products are sold in over 140 countries. Please
visit
www.covidien.com to learn more about our business.
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