NEW YORK, June 12, 2019 /PRNewswire/ -- NYU Langone Health last month became the first center in the United States to perform a discectomy with repair of a large annular defect using a titanium bone-anchored implant newly approved by the U.S. Food and Drug Administration (FDA). The new implantation procedure improves outcomes for patients undergoing discectomy who suffer from radiculopathy and back pain due to herniated disc in the lower back.
Disc herniation is one of the most common causes of lower back and leg pain—or sciatica—in adults. A herniated disc occurs when a fragment of the disc nucleus protrudes through a rupture in the annulus, thereby compressing the nerve, and causing pain. While initial medical treatment often includes rest, medication, and physical therapy, surgical discectomy is recommended for patients who have not had success with these more conservative approaches.
In most discectomy procedures, surgeons remove the protruding piece of nucleus, relieving pressure on the affected nerve and thereby relieving pain. However, one in four patients have a large annular defect in the outer rim of the disc where it ruptured, leaving them vulnerable to repeat herniation.
The device—named Barricaid® and manufactured by Intrinsic Therapeutics—closes the large annular defect with a unique titanium and polyester implant that reduces the risk of reherniation of the disc. In a multicenter, randomized controlled trial examining the efficacy of the device in 554 patients, it reduced the rate of recurrent symptomatic herniation by approximately 50 percent when compared to patients treated with discectomy alone.
Jonathan R. Stieber, MD, clinical assistant professor in the Department of Orthopedic Surgery, and Michael L. Smith, MD, assistant professor in the Department of Neurosurgery and neurosurgeon at NYU Langone's Spine Center, performed the initial procedure.
"We're excited to be the first in the United States to perform discectomy with implantation of the Barricaid, addressing what has been a long unmet need in the field of spine surgery," says Dr. Stieber. "While the current standard of care—discectomy alone—is safe and effective to surgically remove the herniated disc 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," says Dr. Smith. "Implanting the Barricaid device is then immediately performed following the discectomy. The patient should be able to go home after a few hours in the recovery room."
Barricaid received premarket approval for use by the FDA in February 2019, prior to the first U.S. implantation.
"This milestone in spinal surgery procedures demonstrates NYU Langone's commitment to creating the best outcomes for our patients by adopting innovative techniques that are supported by peer-reviewed published evidence," says Joseph D. Zuckerman, MD, the Walter A.L. Thompson Professor of Orthopedic Surgery and Chair of the Department of Orthopedic Surgery. "Our use of cutting-edge treatments serves to both advance the field of orthopedic surgery and improve the quality of life of our patients by reducing their pain, and their risk of re-hospitalization and additional surgery."
NYU Langone's Spine Center provides excellent nonsurgical and surgical treatment of degenerative spine conditions such as herniated disc and spinal stenosis, and spinal deformities including scoliosis and kyphosis. Specialists from NYU Langone's nationally ranked clinical departments of Orthopedic Surgery, Neurosurgery, and Rehabilitation Medicine evaluate 18,000 patients annually and perform 2,850 surgeries and 3,000 interventional procedures a year.
SOURCE NYU Langone Health