FDA's Orthopaedic and Rehabilitation Devices Panel recommended against Premarket Approval of Intrinsic Therapeutics' Barricaid Anular Closure Device for partial anulus replacement to treat herniated discs.
The panel voted 5 to 9 that the device is safe, 12 to 1 (with 1 abstaining) that it is effective in patients for whom it is indicated, and 5 to 8 (with 1 abstaining) that its benefits outweigh the risks.
The Barricaid implant comprises a titanium bone anchor and self-expanding polymer mesh to seal the anulus defect. Its proposed Indication for Use, as stated in the Executive Summary, is for implantation following a limited discectomy, to prevent reherniation and the recurrence of pain or dysfunction.
The device was first implanted in 2Q18, received approval under the CE Mark and launched in the EU one year later. Intrinsic Therapeutics filed its Premarket Application with FDA in 4Q16, based on two-year outcomes of 554 trial subjects with a high risk of reherniation, subsequent reoperation and rehospitalization.
While FDA is not bound by the panel’s recommendation, it typically follows their lead. Should FDA issue premarket approval for device, the advisory committee proposed post-approval five-year follow-up to better demonstrate safety and efficacy vs. control.
Sources: FDA.gov; ORTHOWORLD Inc.