Synthes cervical disc “approvable”
This article was originally published in The Gray Sheet
Swiss firm says Oct. 25 it has received an "approvable" letter from FDA for its ProDisc-C total cervical disc replacement. Final PMA approval is subject to a review of the firm's manufacturing processes. Medtronic's Prestige, approved in July, is the only artificial cervical disc on the U.S. market. An FDA advisory panel also recommended approval of Medtronic's Bryan cervical disc in July (1"The Gray Sheet" July 23, 2007, p. 3)
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Synthes plans surgeon training and a controlled roll-out in January for its ProDisc-C implant to treat cervical disc degeneration. The device received FDA approval Dec. 18 following the completion of a review of the manufacturing processes. Synthes had received an approvable letter from FDA in October 2007 after clinical review of the disc (1"The Gray Sheet" Oct. 29, 2007, In Brief). Medtronic's Prestige, approved in July, is the only other artificial cervical disc on the U.S. market; an FDA advisory panel also recommended approval of Medtronic's Bryan cervical disc in July
FDA's Orthopedic and Rehabilitation Devices Panel overwhelmingly supported approval of Medtronic Sofamor Danek's Bryan artificial cervical spinal disc, while acknowledging that the device's long-term durability is unknown
Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.