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
"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.
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.
Rachel Bloom-Baglin, 508-261-6651
Vice President, Communications
Bruce Farmer, 508-452-4372
Cole Lannum, CFA, 508-452-4343
Todd Carpenter, 508-452-4363