Synthes Gets Approvable Letter from FDA for ProDisc®-C
BY LAUREN UZDIENSKI, OCTOBER 25, 2007
Synthes announced this morning that they received an Approvable Letter from the FDA regarding their PMA application for the ProDisc®-C, the company's artificial cervical disc.
A full approval order will be made once Synthes' manufacturing processes are reviewed by the FDA, at which point the device will be legal for sale in the U.S.
The PMA review included an evaluation of a 209-patient clinical trial conducted over 3.5 years. The study was conducted at 13 clinical sites and compared ProDisc-C to anterior cervical discectomy and fusion. Patients were evaluated for pain and disability, neurologic status and range of motion at the index level. Outcomes included two years of patient follow-up.
Currently, there is one other artificial cervical disc with FDA approval, Medtronic's Prestige. Medtronic's Bryan cervical disc received an FDA panel recommendation for approval in July.
