Barricaid is the only FDA-approved annular closure implant.
Following a lumbar discectomy, the Barricaid device is designed to close large defects (>5mm) in the annulus, which often lead to disc reherniation and/or disc collapse. Barricaid is a permanent implant with two components - an occlusion component and an anchor. The occlusion component is comprised of a flexible polymer material designed to prevent reherniation by physically blocking the annulus at the post-surgery defect. The anchor component is comprised of titanium alloy that is placed into either the caudal or cranial-adjacent vertebral body to secure the device in position.
The Barricaid has been studied in a definitive – level 1B evidence - randomized superiority trial with 554 patients enrolled (clinicaltrials.gov NCT01283438). The study focuses on patient at highest risk of reherniation and reoperation, enrolling only those patients with large defects (width >5 mm). The co-primary endpoints of reherniation and an 8-point composite of safety and effectiveness are evaluated at 2 years, with a parallel cost effectiveness analysis. Peer-reviewed publication of the clinical results is expected in early 2018.
UCSF Grand Rounds w/ Prof. Claudius Thome - State-of-the-Art in Lumbar Herniated Disc treatment:
Barricaid is FDA-approved for sale in the US. Barricaid is not available in Europe.
Brands: Barricaid Annular Closure