Medtronic Sofamor Danek will be the first company to put an artificial cervical disc in front of an FDA advisory panel, the company confirmed Aug. 21.

The Prestige ST , intended to treat degenerative disc disease in the cervical, or neck, region of the spine, could be an alternative to spinal fusion. Proponents of artificial discs believe disc replacement might offer better results than fusion in preserving mobility.

FDA's Orthopaedic & Rehabilitation Devices Panel will vote whether to recommend approval of Medtronic's PMA at a Sept. 19 meeting in Gaithersburg, Md. An Aug. 22 Federal Register notice did not specify the device to be considered, but Medtronic says it will be the Prestige ST.

The product is the first of three Medtronic cervical discs to reach FDA. The company is readying the differently engineered Prestige LP and Bryan systems for future submissions.

Also developing cervical discs are NuVasive ( Cerpass ), Stryker ( CerviCore ), LDR Spine ( Mobi-C ) and Synthes ( ProDisc-C ).

Two firms - J&J/DePuy ( Charité ) and Synthes ( ProDisc ) - have artificial discs approved by FDA for the lower back, or lumbar, region.

Medtronic and NuVasive are the only major spinal manufacturers looking to market cervical products before lumbar discs. Medtronic has said it expects to launch both the Prestige ST and its Maverick lumbar disc next year.

NuVasive believes cervical disc replacement could pose a bigger opportunity than lumbar in the worldwide spine market, estimated at over $3 bil. by the Bank of America.

NuVasive has predicted that disc replacement will penetrate 10%-15% of the lumbar fusion market, whereas it could take closer to 50% of the cervical fusion market (¹ Also see "NuVasive Prepares Cervical Disc IDE Filing; Fusion Plate To Launch In July" - Medtech Insight, 20 June, 2005., p. 15).

Medtronic estimates that approximately 200,000 cervical and 200,000 lumbar procedures are performed annually in the U.S.

- Adosh Unni

Medtronic’s Prestige Artificial Disc Will Be Put To Test At FDA Panel

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