FDA Panel for Bryan Cervical Disc Tomorrow

[mmglobal]

From email I received today...

* MDT HEADS TO PANEL FOR BRYAN CERVICAL DISC TUESDAY, JULY 17: The FDA is scheduled to hold an independent advisory board meeting for orthopedics on Tuesday to discuss a decision on the regulatory status of the Bryan Cervical Disc. Comments from FDA reviewers indicated the Bryan artificial cervical disc is at least as safe and effective as an instrumented fusion with bone graft, the current surgical standard of care for DDD in the cervical spine. The IDE study outcomes seem comparable to those for MDT's Prestige ST artificial cervical disc, which was recommended for FDA approval last fall.

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MDT = Medtronic - interestingly enough, the owner of both Bryan and Prestige discs.

[nopain]

I don't know how to ask this. But when they meet do they decide if it is approved for multiple levels as all the testing in the USA seems to be done on only 1 level.