FDA says “no” to Barricaid for partial annulus replacement in patients with herniated discs

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INTRINSIC LOSES FDA VOTE FOR ANNULAR CLOSURE DEVICE (Orthopedics This Week)
Even before the committee voted, it was not looking good for Intrinsic Therapeutics Inc. and its annular closure device for discectomy patients, Barricaid.
Then the committee voted, and Barricaid’s fate was sealed.
By a margin of 9 to 5, the committee said that there was insufficient evidence of Intrinsic’s annular closure device’s safety when implanted to prevent disc re-herniation. It did vote that Barricaid was effective but, when asked whether the benefits outweighed its risks, the committee said “no” by a vote...

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