For the first time in the United States, titanium bone-anchored implants were used to repair large annular defects during diskectomies. These surgeries were initially performed in May 2019 at New York University (NYU) Langone Medical Center following US Food and Drug Administration premarket approval of the Barricaid device (developed and manufactured by Intrinsic Therapeutics) in February 2019.

This device, which includes an occlusion component made of woven polyester, and a titanium bone anchor for its tethering to the vertebral body, was designed to prevent the reoccurrence of disk herniation through the blocking of large defects in the annulus fibrosus. The device also allows for greater disk preservation.

The Barricaid device is intended for patients with back pain and radiculopathy associated with disk herniation in the lower back who have not benefited from conventional treatment and have large annular defects that are susceptible to recurring herniation. An alignment trial allows to determine angle and access to disk space for implantation, which is confirmed by fluoroscopy.

Results from a multicenter randomized controlled trial (n=554) indicated that use of the Barricaid device during diskectomy was associated with a reduction in the recurrence of symptomatic herniation by approximately 50% compared with conventional diskectomy.

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“We are excited to be the first in the United States to perform diskectomy with implantation of the Barricaid, addressing what has been a long unmet need in the field of spine surgery,” declared Jonathan R. Stieber, MD, clinical assistant professor in the Department of Orthopedic Surgery at NYU Langone’s Spine Center, who performed the initial surgery. “While the current standard of care — diskectomy alone — is safe and effective to surgically remove the herniated disk material, we have not yet had a reliable way to avoid reherniation in a certain high-risk population.”

“We determine during surgery if the patient has an annular defect that could benefit from repair. Implantation of the Barricaid device is then immediately performed following the diskectomy. The patient should be able to go home after a few hours in the recovery room,” added Michael L. Smith, MD, neurosurgeon at NYU Langone’s Spine Center, who also carried out the initial surgery.

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Reference

New York University Langone Medical Center Press Release. NYU Langone performs first U.S. procedure with newly approved device to reduce herniated disc recurrence. https://nyulangone.org/press-releases/nyu-langone-performs-first-us-procedure-with-newly-approved-device-to-reduce-herniated-disc-recurrence. June 12, 2019. Accessed June 17, 2019.