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...