FDA approval expected for lumbar artificial disc
October 27, 2004
IDE Study Results Show Patients Return to Active Life More Quickly
CHICAGO, IL—October 27, 2004—People who’ve suffered for years from the pain of degenerative and herniated discs now have an option that may relieve the pain, allow them quick recovery and enable them to lead active and productive lives. The Food and Drug Administration (FDA) approval of the Charité Artificial Disc is expected sometime within the month. The approval follows the recommendation of the FDA device panel back in June. The Chicago Institute of Neurosurgery and Neuroresearch (CINN) medical group was the only physician group in Chicago to participate in the investigational device exemption (IDE) study for this artificial disc. Results show that artificial disc patients have shorter hospital stays, less post-operative pain and they return to daily activities more quickly than those who have spinal fusion surgery. Read more
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