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St. Francis predicts X-Stop launch in mid-2005

This article was originally published in The Gray Sheet

Executive Summary

FDA-requested information to support approval for firm's X-Stop non-fusion lumbar device is "reasonable" and "readily available," President & CEO Kevin Sidow states. St. Francis will submit the requested data quickly, he says. In September, FDA's Orthopaedic & Rehabilitation Devices Panel voted 5-3 against approval of the device, which is meant to treat lumbar spinal stenosis, due to a lack of radiographic data proving reduction of stenosis-induced pressure on spinal nerve roots (1"The Gray Sheet" Sept. 6, 2004, p. 7). Sidow believes X-Stop is on track for a mid-2005 release in the U.S. Currently, the device is approved in Europe and Japan...

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