Covidien Announces FDA Advisory Committee Unanimously Recommends Approval for Pipeline(TM) Embolization Device

MANSFIELD, Mass., Mar 18, 2011 (BUSINESS WIRE) —

Covidien (NYSE:COV), a leading global provider of healthcare
products, today announced that the U.S. Food and Drug
Administration (FDA) Neurological Devices Advisory Panel voted to
recommend approval for Pipeline(TM) Embolization Device, intended
for the endovascular treatment of large or giant wide-necked
intracranial aneurysms in the cavernous and paraclinoid regions of
the internal carotid artery.

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.

At its meeting today, the FDA Advisory Panel discussed the
Premarket Approval (PMA) application for the Pipeline Embolization
Device. Following its review of the PMA data, the Panel voted
unanimously to recommend approval. Although the FDA is not required
to follow Panel recommendations, it often does.

The Pipeline Embolization Device PMA application is based on the
results of the PUFS (Pipeline for Uncoilable or Failed AneurysmS)
clinical study that included safety and efficacy data on 108
patients. PUFS is a single-arm study of large and giant, wide-neck
or fusiform aneurysms typically not coilable, with six-month safety
and effectiveness endpoints.

“Safe and effective treatment of large and giant, wide-neck or
non-saccular aneurysms remains a significant unmet clinical need,”
said Aaron Berez, M.D., General Manager, Neurovascular, Covidien.
“Clinical experience suggests that the Pipeline Embolization Device
may represent a valuable alternative to current endovascular or
surgical treatment options for these types of aneurysms.”

“The Pipeline Embolization Device represents a breakthrough
endovascular treatment for large, giant and wide-neck aneurysms
that are very difficult or impossible to treat with existing
therapies such as surgery or coiling,” said Joe Woody, President,
Vascular Therapies, Covidien. “We believe strongly that the PMA
data that was submitted from the PUFS clinical study supports the
safety and efficacy of this device.”

The Pipeline Embolization Device has received CE Mark approval
in Europe and has been sold outside the United States since July
2009.

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.

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