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Covidien Pipeline Embolization Device Proving Effective for Giant Aneurysms

June 17th, 2013 Medgadget Editors Neurosurgery, Radiology

Covidien-PipelineCovidien is touting results published in this month’s journal Radiology of a U.S. clinical trial of its Pipeline embolization device. The trial, which involved 108 patients with large and giant wide-necked intracranial aneurysms, had as its primary endpoint successful aneurysm occlusion and absence of major stenosis six months post implantation.

The study found that 73.6% of the treated patients had their aneurysms completely closed using only the Pipeline device. Importantly, the complete occlusion rate continued to improve, reaching 86.8%  at one-year follow-up, an impressive result for patients at grave risk of stroke and death.

From the study abstract:

Results: PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study’s primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%–81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%–11.7%).

Conclusion: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

Flashbacks: Pipeline Embolization Device Gets FDA Panel Recommendation; Pipeline Embolization Device Wins U.S. Regulatory Approval

Study in Radiology: Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial

Press release: Covidien Announces Publication of Final Results of Pipeline™ Embolization Device Pivotal Study

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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