Researchers offered mixed messages on the safety and effectiveness of Covidien (NYSE:COV) subsidiary ev3 Inc.’s Pipeline embolization device, lauding the system as an option for patients with aneurysms that may not otherwise be treatable but warning of a significant risk of serious complications.
Researchers conducting post-market research on the PED reported "promising results" for the treatment, which diverts blood away from a brain aneurysm and promotes vessel tissue growth that blocks off the aneurysm over time, rather than providing immediate occlusion.
"Although treatment may take months to complete, the aneurysm is eventually completely occluded in most patients," according to a press release. "Thus the PED offers an effective new option for patients with aneurysms that would previously have been difficult or impossible to treat."
The treatment also comes with significant risks, researchers warned. Of the 56 patients treated in the post-market study, 4 died from brain bleeds within 2 months of implantation, according to the report.
Overall the data showed an 8.5% of major complications or death associated with the device. Some patients needed additional procedures related to deployment issues with the PEDs and 6 patients had clots that lead to strokes or transient ischemic attacks after the procedure.
However, of the 19 patients for which 3-month follow-up data was available 68% had achieved full occlusion of the affected vessels in the brain, and most of the patients that suffered post-procedure strokes had aneurysms at the base of the brain, where 3 arteries meet, researchers noted.
The data raised concerns about the risks of fatal bleeding and other potential complications associated with the device, and the researchers warned against any off-label use of the PED until more long-term data can be collected.
The findings were similar to clinical results gathered in advance of U.S. approval for eV3’s PED. The device won FDA approval in 2011 for treatment of certain aneurysms.
Covidien acquired eV3 ev3 in the summer of 2010, paying $2.6 billion in cash for the stent, catheter and balloon maker. Covidien reported earlier this year that the PED has seen "a tremendous amount of proliferation across the globe."