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Orthopedic and Dental Industry News Complete Archive »

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD, SEPTEMBER 20, 2006

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System.

After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded that Prestige compared to fusion:
-Is as effective as, not necessarily better than, fusion
-Provides equal pain reduction and improvements in the ability to conduct movements that were difficult preoperatively
-Does not pose a significant increase in cancer risk (despite the fact that 5 Prestige patients vs. 2 fusion patients developed cancer)
-Had the same low level of adverse events but the number of surgery-related side effects (pain or implant displacement) was lower in the Prestige group compared with the fusion group

The FDA's final decision usually follows the panel's recommendations. The next step will be for the FDA to review PRESTIGE's Premarket Approval (PMA) application which is subject to additional conditions around labeling and post-approval testing. Yesterday's panel recommended that the device be studied for several years and that Medtronic conduct a study in animals to analyze what impact, if any, the post implantation debris has on humans.

After approval, the next hurdle for Medtronic will be gaining Medicare reimbursement of their cervical disc.

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