www.fdanews.com/articles/88236-fda-approves-clinical-trial-for-medtronic-s-diam-spinal-stabilization-system
FDA APPROVES CLINICAL TRIAL FOR MEDTRONIC'S DIAM SPINAL STABILIZATION SYSTEM
July 10, 2006
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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