Intrinsic Therapeutics has won FDA premarket approval for its Barricaid anular closure device intended for preventing reherniation, according to a recent FDA posting.
The approval comes despite the fact that the prosthesis, which is designed for partial anulus replacement in patients with herniated discs, received a 5-8 advisory panel against recommending approval in December 2017.
The Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body. The device is intended an adjunct for lumbar limited discectomy to replace missing or damaged parts of the anulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.
The negative recommendations from the panel came based on concerns over the safety of the device, including breakage rate and certain endplate lesions of unknown origin. The same panel voted 12 to 1 in favor of the device’s efficacy, however.
The recent approval of the device came backed by data from a two-year clinical trial of 554 patients, the results of which were published in The Spine Journal last May. The study met both its co-primary endpoints, with data indicated a lowered risk of symptomatic recurrence and reoperation.