BOSTON, MA – January 25, 2022 via PRNewsWire (Link)
Intrinsic Therapeutics, Inc., a medical device company focused on preventing reherniation and reoperation following lumbar discectomy, today announced the publication in JAMA Network Open of the five-year follow-up results from its landmark clinical trial demonstrating that the use of Barricaid following discectomy is superior to treating high-risk patients with discectomy alone.
The results of the 554-patient, randomized superiority trial indicate statistically significant reductions over the five-year period for both reherniation (41% reduction, p<0.001) and reoperation (29% reduction, p=0.03). This keystone publication adds to a robust body of evidence including 64 peer-reviewed manuscripts detailing eight distinct patient populations.
“The five-year follow-up analysis makes it clear that lumbar discectomies are not as benign as we originally thought. The JAMA study results conclusively show high-risk lumbar discectomy patients treated with Barricaid are less likely to suffer reherniation and reoperation than those patients treated with discectomy alone,” said Professor Claudius Thomé, Head of Neurosurgery at the University of Innsbruck, Austria, and Principal Investigator of this trial.
In addition, the rates of serious adverse events related to either the implant and/or procedure were significantly lower in the patients treated with Barricaid (12.0% vs 20.5%) (P=0.008), indicating that use of the Barricaid lowers the incidence of complications leading to costly hospital readmissions.
“Not surprisingly, patients who have operations for reherniation don’t generally experience the same pain and functional improvement as patients not requiring additional surgery,” explained Dr. Pierce Nunley, Director of the Spine Institute of Louisiana and Principal Investigator. “With the proven reduction in reoperation, this large, multicenter study reaffirms and compliments a large body of published evidence supporting Barricaid’s medical and economic benefits.”
“The JAMA study results conclusively show high-risk lumbar discectomy patients treated with Barricaid are less likely to suffer reherniation and reoperation than those patients treated with discectomy alone.”
– Prof. Dr. Claudius, Thomé
Barricaid is backed by 7 clinical studies, demonstrating an 81% reduction in reoperations for reherniation. Click to learn more and speak with a clinical researcher.
About herniation and lumbar discectomy
Radiating pain in the leg is often caused by a herniated lumbar disc compressing the nerve. Since this condition mostly affects a relatively young, active patient population, the social and economic consequences resulting from disability and absenteeism from work are significant. Surgery for a herniated disc is generally only considered when conservative treatment options have failed.
Many patients undergoing a discectomy surgery for a herniated lumbar disc are at high risk of reherniation and reoperation. With nearly 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 designed Barricaid to prevent reherniation and reoperation following lumbar discectomy surgery. Over the last 13 years, Barricaid has been implanted in thousands of patients and has been rigorously studied through multiple trials, including a multicenter level I RCT demonstrating superior outcomes to discectomy alone leading to FDA Pre-Market Approval in 2019. See www.barricaid.com for more information.
Media contact person:
Jake Tanner, Senior Director, Marketing
760-525-9739
Jtanner@barricaid.com
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.