FDA Advisory Panel Says Yes to New Aneurysm Device

Fran Lowry

March 21, 2011

March 21, 2011 — The US Food and Drug Administration's (FDA's) Neurological Devices panel has voted unanimously to endorse approval of the Pipeline embolization device (PED) for the endovascular treatment of wide-neck large or giant intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.

All 8 voting members of the panel voted yes to the 3 standard voting questions that asked if there was reasonable assurance that the PED was safe and effective and that its benefits outweighed its risks.

Even though there were 9 questions for the FDA expert panel, members breezed through their deliberations to finish 3 hours before the designated adjournment time listed on the agenda.

Scott R. Evans, PhD, the statistician on the panel from Harvard University, Boston, Massachusetts, thanked the sponsor, Chestnut Medical Technologies, of Menlo Park, California, as well as the FDA, for their efforts in presenting their data.

"For most of these meetings, I have to provide a detailed biostatistics lecture on why the data are not as strong as is being purported to be, and I didn't have to do that today," he said. "I think I had some minor issues with the way some individual patient data was handled in the analysis but it turns out that even under alternative analyses, those patients were so few and the data were so strong, that it didn't affect the qualitative outcome of the interpretation, and so I think in this case the data spoke for itself. The data were strong."

For most of these meetings, I have to provide a detailed biostatistics lecture on why the data are not as strong as is being purported to be, and I didn't have to do that today.

Chestnut showed that the device, which has been in use in 52 countries outside of the United States for 2 years, was 74% effective in achieving complete aneurysm occlusion in the absence of stenosis greater than 50% in its pivotal Pipeline for Uncoilable or Failed Aneurysms (PUFS) study.

Andrew Ku, MD, from Allegheny General Hospital, Pittsburgh, Pennsylvania, also lauded the sponsor and the FDA, "for the way they developed their protocol and the way it was structured. The questions that they evaluated seemed to answer all the appropriate concerns," he said.

US Food and Drug Administration Neurological Devices Panel Meeting, Gaithersburg, Maryland, March 18, 2011.

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