Adjacent to 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 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-Approved
For full risk/benefit, see: www.barricaid.com/instructions-for-use
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-Approved
For full risk/benefit, see: www.barricaid.com/instructions-for-use
Location: United States, Massachusetts, Woburn
Employees: 11-50
Phone: +1 781-932-0222
Founded date: 2000
Investors 2
| Date | Name | Website |
| - | New Enterp... | nea.com |
| - | Questa Cap... | questacapi... |
Mentions in press and media 1
| Date | Title | Description |
| - | Intrinsic Therapeutics | “ Barricaid bone-anchored implant is first device clinically proven to reduce incidence of reherniation and reoperation in herniated disc surgery patients.” |