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A retrospective analysis of microscopic evaluation data from control (device and/or saline-treated) animals in intrathecal studies in monkeys, dogs, sheep, and rats was conducted. The studies were performed by multiple testing facilities. All slide preparation and microscopic evaluation were conducted in the laboratory of the author. The data were of observations made at the level of the catheter tip, which typically was located in the intrathecal space near the thoracolumbar region of the spinal canal. The most common microscopic changes in control animals were meningeal infiltrates, catheter track (CT) inflammation, spinal cord compression (at the CT), CT fibrosis, spinal cord gliosis (at the CT), and spinal cord nerve fiber degeneration. Although variable between studies (even within species), in general the average severity of these findings was minimal or less in control animals. CT inflammatory mass/pyogranuloma formation, a known complication following the administration of morphine at higher concentrations/doses, was noted in 3 of 25 control dogs and 2 of 77 control monkeys. These data show that inflammatory mass/pyogranuloma formation may occur in control animals, and this occurrence is most common in dogs as compared to monkeys, sheep, and rats.

Morphologic Changes Associated with Intrathecal Catheters for Direct Delivery to the Central Nervous System in Preclinical Studies