FDA Approves Titanium/Polyester Device for Radiculopathy and Back Pain
Newswise — 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.”
Read the full press release.
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