Health and Fitness Health and Fitness
Thu, March 31, 2011
Wed, March 30, 2011
Tue, March 29, 2011
Mon, March 28, 2011
Sun, March 27, 2011
Fri, March 25, 2011
Thu, March 24, 2011
Wed, March 23, 2011
Tue, March 22, 2011
Mon, March 21, 2011
[ Mon, Mar 21st 2011 ] - Market Wire
30 p.m. ET
Sun, March 20, 2011
Fri, March 18, 2011
Thu, March 17, 2011
Wed, March 16, 2011
Tue, March 15, 2011
Mon, March 14, 2011
Sun, March 13, 2011
Sat, March 12, 2011
Fri, March 11, 2011
[ Fri, Mar 11th 2011 ] - Market Wire
Covidien????????????????FDA??
Thu, March 10, 2011
Wed, March 9, 2011

Covidien Announces FDA Advisory Committee Unanimously Recommends Approval for Pipelinea" Embolization Device


//health-fitness.news-articles.net/content/2011/ .. -approval-for-pipelinea-embolization-device.html
Published in Health and Fitness on Friday, March 18th 2011 at 12:50 GMT by Market Wire   Print publication without navigation


MANSFIELD, Mass.--([ 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 Pipelinea" 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.

"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"

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.

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

aThe 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,a said Joe Woody, President, Vascular Therapies, Covidien. aWe believe strongly that the PMA data that was submitted from the PUFS clinical study supports the safety and efficacy of this device.a

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.


Publication Contributing Sources