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DynaMed Systems, LLC
DynaMed Systems Obtains FDA Approval to Study Its Traxon Spinal Cord Repair Stimulation System in Acute Spinal Cord Injured SCI Patients
May 18th, 2008
DynaMed Systems, LLC announced that the U.S. Food and Drug Administration (FDA) has approved its investigational Device Exemption (IDE) Application to study the Traxon(R) Spinal Cord Repair Stimulation System (TRAXON(R) System) in acute spinal cord injured patients. The study is designed to assess the safety and effectiveness of the TRAXON(R) System, a surgically implanted DC powered device, to improve motor function and other functional assessments in acute complete and incomplete SCI patients. DynaMed Systems' proprietary technology applies oriented and linear electrical fields to damaged nerve fibers. The clinical study will test the ability of the device to safely...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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