In Brief: Gliatech's Adcon-L
This article was originally published in The Gray Sheet
Executive Summary
Gliatech's Adcon-L: FDA's Orthopedic and Rehabilitation Devices Panel recommends approval of anti-adhesion product at a Dec. 12 meeting in Bethesda, Maryland. Adcon-L, a porcine-derived polymer gel, is indicated for use in reducing post-surgical peridural fibrosis (scar tissue that forms around the dura) and adhesions in posterior single-level (L4-L5 or L5-S1) laminectomy surgery. The nine committee members had differing opinions on whether data included in the firm's PMA supported proposed claims that the product reduced residual pain associated with peridural scarring despite data presented from the firm's European pivotal trial showing a statistically significant reduction in activity-related pain. Six-month results of the triple-blinded, multicenter, European trial, which included 267 available patients, showed that use of Adcon-L on patients compared to no treatment reduced by 12 percentage points (50% versus 38%) the number of patients with extensive scarring post-surgery. Efficacy was assessed by the amount of peridural scar found by a blinded neurologist on magnetic resonance imaging scans centered on the operated intervertebral space. U.S. clinical trials are still ongoing...
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