Spine device to prevent spinal disc herniation wins PMA after setback

Device to prevent spinal disc herniation wins PMA after setback (MedTechDive)

Barricaid

Website - Intrinsic Therapeutics Dive Brief:

Intrinsic Therapeutics has received FDA premarket approval for its Barricaid annular closure device used in spinal surgery to prevent recurrent disc herniation. The authorization comes more than a year after an FDA advisory panel, by a 9-5 vote, recommended against approving the device based on safety concerns. That panel also voted 12-1 in favor of the effectiveness of the device. Barricaid is designed to close large defects in the an...


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