MANSFIELD, Mass., Apr 06, 2011 (BUSINESS WIRE) —
Covidien (NYSE:COV), a leading global provider of healthcare
products, today announced that it received Premarket Approval (PMA)
from the U.S. Food and Drug Administration (FDA) for the
Pipeline(R) Embolization Device, 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.
Pipeline is a new class of embolization device designed to
divert blood flow away from the aneurysm in order to provide a
complete and durable aneurysm embolization while maintaining
patency of the parent vessel.
A cerebral aneurysm is a weak spot in the wall of a blood vessel
within the brain, characterized by an abnormal “ballooning” or
widening of the vessel. A brain aneurysm ruptures every 18 minutes
and 40% of these cases are fatal. Of those who survive, about 66%
suffer some permanent neurological deficit.1
“The Pipeline Embolization Device is a breakthrough and
life-saving endovascular treatment for large or giant wide-neck
brain aneurysms,” said Joe Woody, President, Vascular Therapies,
Covidien. “Pipeline now offers hope for those patients who have had
no other options for treating this often debilitating and even
fatal medical condition.”
The Pipeline Embolization Device PMA application was based on
the results of the PUFS (Pipeline for Uncoilable or Failed
Aneurysms) clinical study, a single-arm study of large and giant,
wide-neck or fusiform aneurysms that included safety and efficacy
data on 108 patients.
“Brain aneurysms are a silent killer because most show no
symptoms over time,” said Christine Buckley, Executive Director,
The Brain Aneurysm Foundation. “The Pipeline Embolization Device
now provides patients with a safe and effective treatment of large
or giant, wide-neck aneurysms, which remained an unmet clinical
need until now.”
The Pipeline Embolization Device has received CE Mark approval
in Europe and has been sold outside the United States since July
2009. The Pipeline device will be available at the existing
clinical sites in the U.S. beginning this quarter.
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 approximately 42,000 employees worldwide in
more than 60 countries, and its products are sold in over 140
countries. Please visit
www.covidien.com to learn more about our business.
1Brain Aneurysm Foundation.
http://www.bafound.org/Statistics_and_Facts
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