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 annulus, the tough circular exterior of the intervertebral disc, allowing the surgeon to preserve more of the patient's disc, according to the company's website.
Dive Insight:
The device is intended to prevent re-herniation of the disc. It consists of a woven polyester occlusion component intended to block the annular defect while anchored to the adjacent vertebral body by a titanium bone anchor.
A two-year clinical trial of 550 patients published in The Spine Journal found the device compared to standard treatment was statistically superior on all endpoints, including recurrent herniation and ...
