DynaMed Granted FDA Approval to Study Traxon System
April 29, 2008
DynaMed Systems has announced that the FDA has approved its investigational device exemption application to study the Traxon spinal cord repair stimulation system in acute spinal cord injured patients.
The study is designed to assess the safety and effectiveness of the Traxon System to improve motor function and other functional assessments in acute complete and incomplete spinal cord injured patients.
DynaMed’s proprietary technology applies oriented and linear electrical fields to damaged nerve fibers. The clinical study will test the ability of the device to safely repair and improve function in those damaged nerves. The pilot study will include 24 patients between the ages of 18 and 73 who have suffered a recent spinal cord injury.