Intrinsic Therapeutics Inc.
Hospital/Clinic - Woburn, MA, US
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Adjacent to a lumbar discectomy, the Barricaid® device is designed to close large defects in the annulus, which often lead to disc reherniation and/or disc collapse. Barricaid is a permanent implant with two components - a titanium bone anchor and a flexible polymer barrier. The barrier is 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 over 550 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. Treated patients were found superior on both endpoints, with significantly lower rates of symptomatic recurrences (12% vs. 25%, p<0.001), index-level reoperations (9% vs. 16%, p=0.01), and device or procedure related serious adverse events (SAEs) (7% vs. 17%, p=0.001). Through two years, a total of 29 reoperations were performed in Barricaid subjects in comparison to 61 procedures in Controls. Study results are published in The Spine Journal, May 2018.Barricaid is FDA-ApprovedFor full risk/benefit, see: www.barricaid.com/instructions-for-use
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