Trial Demonstrates Safety and Effectiveness of Covidien's Pipeline Embolization Device for Treating Complex Intracranial Aneurysms

June 25, 2013—In Radiology, Tibor Becske, MD, et al published findings from an evaluation of the safety and effectiveness of the Pipeline embolization device (Covidien, Mansfield, MA) for the treatment of complex intracranial aneurysms (2013;267:858–868).

The investigators concluded that the Pipeline device offers a reasonably safe and effective treatment for 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 in which previous alternative treatments failed.

As summarized in Radiology, the Pipeline for Uncoilable or Failed Aneurysms study was a multicenter, prospective, interventional, single-arm trial of the Pipeline embolization device for the treatment of uncoilable aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was the occurrence of major ipsilateral stroke or neurologic death at 180 days.

The investigators reported that Pipeline device placement was technically successful in 107 of 108 patients (99.1%). The 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%). 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%), according to the study's abstract in Radiology.

The Pipeline embolization device received CE Mark approval in Europe and has been sold outside the United States since July 2009. In 2012, the device received US Food and Drug Administration approval. Pipeline was developed and introduced by ev3 Inc. (Plymouth, MN), which was acquired by Covidien in a transaction announced on June 1, 2010.