Covidien (NYSE:COV) subsidiary ev3 Inc. is touting the results of a pivotal trial of its Pipeline aneurysm embolization device, showing that the technology "offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms."
The study, published in the June issue of Radiology, a peer-reviewed medical journal of the Radiological Society of North America, followed 108 patients with recently unruptured large and giant wide-necked aneurysms.
Of the patients enrolled, 74% met the study’s primary effectiveness endpoint of aneurysm occlusion and absence of major stenosis at 180 days without further treatment, according to the journal. Six of the patients studied experienced a major ipsilateral stroke or neurologic death.
Investigators compared the Pipeline device against a historical control group because no similar devices are available in the U.S., according to a company release.
Covidien, which acquired stent, catheter and balloon maker eV3 in the summer of 2010 for $2.6 billion in cash, received FDA approval for the Pipeline device in March 2011.