'Pipeline' Device Offers New Option for Difficult-to-Treat Brain Aneurysms

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"The study reflects the increased emphasis on collecting post-marketing data on newly approved medical devices to see if the results in initial clinical experience are comparable to those in research trials."

A new technology called the Pipeline embolization device (PED) shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, reports the December issue of Neurosurgery, official journal of the Congress of Neurological Surgeons.

Data collected since the PED was approved for marketing show generally good results in "real world" clinical practice. However, the report raises concerns about fatal bleeding and other serious complications, especially for aneurysms in one specific location. The lead author of the study was Dr. Peter Kan of University at Buffalo, N.Y.

The researchers evaluated "early postmarket" results -- that is, after approval by the U.S. Food and Drug Administration (FDA) -- using the PED at seven surgical centers. . .View Full Article

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