INTRINSIC LOSES FDA VOTE FOR ANNULAR CLOSURE DEVICE (Orthopedics This Week)
Even before the committee voted, it was not looking good for Intrinsic Therapeutics Inc. and its annular closure device for discectomy patients, Barricaid.
Then the committee voted, and Barricaid’s fate was sealed.
By a margin of 9 to 5, the committee said that there was insufficient evidence of Intrinsic’s annular closure device’s safety when implanted to prevent disc re-herniation. It did vote that Barricaid was effective but, when asked whether the benefits outweighed its risks, the committee said “no” by a vote of 8 to 5, with 1 abstaining.
The vote by the FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee occurred on December 12, 2017.
FDA Staff Concerns
But, really, the committee’s outcome was probably pre-ordained based on the FDA staff instructions where both the study methodology and safety were called into question.
Barricaid’s study, which was a prospective, randomized investigation, recruited 554 discectomy patients of which 276 were randomized to Barricaid after a discectomy while the remaining 278 received discectomy alone.
The patients were followed f...
