Covidien 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
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