Intrinsic Therapeutics
Intrinsic Therapeutics developed the Barricaid bone-anchored implant, the first FDA-approved device proven to reduce reherniation and reoperation in patients with large annular defects.
Barricaid Implant Overview
The Barricaid bone-anchored implant is the first device clinically proven to reduce the incidence of reherniation and reoperation in patients with large annular defects. Designed to close large holes in the disc wall, Barricaid reduces the need for a second operation by 81%. It includes a titanium anchor and a polymer plug to repair and reconstruct the disc wall, intended for skeletally mature patients with certain disc herniation conditions. The device has shown to withstand 330 pounds per square inch of pressure.
FDA Approval and Availability
Barricaid received FDA Pre-Market Approval in 2019, making it available for sale in the United States. Despite its clinical success and widespread use, the Barricaid implant is not available in Europe. The Centers for Medicare and Medicaid Services (CMS) issued a C-code for hospitals and surgery centers to report for billing and payment for Barricaid in 2020. Furthermore, the Centers for Disease Control issued ICD-10 codes to track and monitor defect size in discectomy patients in late 2022.
Clinical Studies and Trials
Barricaid has been rigorously studied through multiple trials. It was proven safe and effective in a study presented to the FDA. Clinical studies show that patients benefit from significantly reduced disc reherniations and reoperations, with over 10,000 patients receiving the implant to date. The device has been studied in eight distinct patient populations, including two randomized controlled trials and six single-armed trials. A multicenter level I RCT demonstrated superior outcomes compared to discectomy alone.
Patient Outcomes with Barricaid
Patients receiving the Barricaid implant were able to return to work an average of 3.6 weeks later, significantly faster than the 9-week average noted in recent discectomy studies. Barricaid is specifically designed for patients at high risk of discectomy failure and who do not want to risk a second surgery. Clinical studies indicate that Barricaid patients experience significantly reduced rates of disc reherniations and reoperations.