Clinical study shows device safety and effectiveness
COLORADO SPRINGS, Colo.--(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® 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.
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.
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
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