Pivotal Clinical Trial Demonstrates Superiority of Anular Closure Compared to Standard Lumbar Discectomy
BOSTON, May 23, 2018 /PRNewswire/ -- Intrinsic Therapeutics, Inc., a medical device company focusing on spinal disc therapies, today announced the publication of two-year results from a landmark, randomized, superiority clinical trial. The trial investigated the Barricaid Anular Closure Device (ACD) in comparison to today's gold standard of discectomy without anular closure, for patients at higher risk of recurrent lumbar disc herniation.
The clinical trial included 554 randomized patients. Its purpose was to determine whether a microdiscectomy with a bone-anchored anular closure device resulted in lower reherniation and reoperation rates and increased overall patient clinical success, when compared to traditional lumbar discectomy without defect closure.
The two-year results that have now been published in The Spine Journal demonstrate that the use of a bone-anchored ACD following discectomy is superior to treating these high-risk patients with discectomy alone. The group treated with Barricaid had significantly lower rates of reherniation (12% vs. 25%, P <0.001), reoperations to address recurrent herniation (5% vs. 13%, P=0.001), and index-level reoperations (9% vs. 16%, P =0.01).
"In order to fully comprehend the benefit of treating these patients with an implant, it is important to realize that patients who are reoperated generally do not reach the same pain and functional improvement of patients who did not have additional surgery. The odds of not returning to work were nearly three times higher after a revision surgery. Barricaid cuts the rate of reoperations in half at 2 years, preventing chronic disability and improving quality of life," explains Dr. Matthew McGirt, Adjunct Research Associate Professor at the University of North Carolina, who was not involved in the study.
In addition, the rates of serious adverse events related to either the implant and/or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001), indicating that use of the Barricaid lowers the incidence of hospital readmissions.
"These study results shine a spotlight on the fact that if we add a device to a procedure that doesn't otherwise have one, the treatment cohort experiences fewer related hospital readmissions, with a 40% reduction at two years. According to current follow-up data of up to five years this differential is maintained," says Professor Claudius Thomé, Head of Neurosurgery at the University of Innsbruck, Austria, and one of the principal investigators of this trial. "Moreover, if a reoperation needs to be considered in a patient later on, the same revision strategies are possible with this implant as after microdiscectomy alone."
About herniation and lumbar discectomy
The human intervertebral disc consists of an outer fibrous ring, the anulus fibrosus, which in case of herniation allows the inner gel-like center, nucleus pulposus, to come out through a defect in the anulus. Sciatica, characterized as radiating pain in the leg, is often caused by a herniated disc compressing the nerve. The estimated annual incidence of sciatica in Western countries is 5 cases per 1,000 adults. As it mostly affects a relatively young, active patient population, the economic consequences resulting from disability and absenteeism from work are significant. Surgery for a herniated disc is often only considered when conservative treatment options have failed.
Within the discectomy population, patients with large defects in their anulus following lumbar discectomy are at high risk of symptomatic recurrence and reoperation. According to literature, 30-40% of all discectomy patients fall into this group. With almost 500,000 discectomies performed annually in the United States alone, this poses a significant problem not only for the patients affected, but for society as a whole.
About Intrinsic Therapeutics
Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic Therapeutics currently markets and sells the Barricaid in Europe, Australia, Mexico, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. See www.barricaid.com for more information.
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
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SOURCE Intrinsic Therapeutics, Inc.
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