PUFS clinical study results show device safety and effectiveness

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The Pipeline embolization device (Covidien) met the trial primary endpoints for both effectiveness and safety, according to results from the PUFS (Pipeline for uncoilable or failed aneurysms) clinical study presented at the Society of NeuroInterventional Surgery 8th Annual Meeting, on 27 July 2011.

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 device disrupts the flow of blood from the parent artery into the aneurysm, and re-endothelialisation, where Pipeline 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, minimising the risk of rupture, as well as recanalisation.

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