FDAnews Device Daily Bulletin

FDA APPROVES CLINICAL TRIAL FOR MEDTRONIC'S DIAM SPINAL STABILIZATION SYSTEM

July 11, 2006
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Medtronic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to the DIAM Spinal Stabilization System for use in a clinical study. This approval will allow Medtronic to begin the first of three planned clinical trials in the U.S. and Europe. The DIAM System is designed to alleviate pain in degenerative stenosis patients who suffer predominantly from radiating leg discomfort and moderate low back pain and is the only non-rigid interspinous spacer under clinical investigation.
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