Intrinsic Therapeutics Announces the Enrollment of the 400th Patient in Landmark Barricaid® Randomized Trial
WOBURN, Mass., Aug. 1, 2013 /PRNewswire/ -- Intrinsic Therapeutics today announced the enrollment of the 400th patient in a level 1, prospective, randomized, multi-center clinical trial evaluating the effectiveness of its Barricaid Prosthesis in improving outcomes for lumbar discectomy patients suffering from sciatica. The surgery was performed by Dr. Frederic Martens in Aalst, Belgium. The study is being conducted in Germany, Switzerland, Austria, and The Benelux with the goal of demonstrating fewer disc reherniations and improved function in high-risk patients treated with the Barricaid compared to limited discectomy only.
"Today's standard discectomy procedure is performed in such a manner that an opening remains in the outer structure of the disc at the end of the surgery. The scientific literature is clear that these open anular defects may result in a 10-15% incidence of reherniation, subsequent collapse and degeneration of the disc." said Prof. Claudius Thome, Director of Neurosurgery at the Innsbruck Medical University. "This randomized study presents a great opportunity to document, with a high level of scientific evidence, whether closing the anular defect avoids a reherniation, preserves the disc and improves outcomes."
In addition to studying the safety and effectiveness of the Barricaid device, the information gathered from the trial will allow correlation analyses of a multitude of clinical variables that have never before been possible. The project investigates both clinical and radiographic information related to disc degeneration by studying effects of age, smoking status, BMI, musculoskeletal health, and dozens of other potential contributors to chronic low back pain.
"With twenty-one centers involved in the trial, we believe that this is the largest and most comprehensive study ever performed to investigate the effects of discectomy in the lumbar spine," said Jacob Einhorn, Intrinsic Chief Operating Officer. "We have a fantastic team of clinical professionals who are executing this project according to GCP, ISO, and 21-CFR guidelines to assure the highest possible level of data integrity to meet standards for regulatory and reimbursement approvals. In this age of tightened healthcare budgets, new technologies must demonstrate cost effectiveness. This study incorporates the key economic impact factors of discectomy failures and will measure the potential for the Barricaid to reduce overall costs."
About the Barricaid Prosthesis
Discectomy is the most frequently performed surgical procedure on the lumbar spine. Designed for patients who present with primary disc herniation and large anular defects, the Barricaid device is engineered to close the defect in order to prevent future reherniations and to retain pressure within the disc. Closing the anular defect is intended to reduce the risk of reherniation, preserve the internal nucleus material, and provide the opportunity for disc height maintenance. The addressable patient population for the Barricaid product includes patients with lumbar disc herniations with or without back pain and represents the largest unmet need in the spine market.
About Intrinsic Therapeutics
Intrinsic Therapeutics is dedicated to the science of spinal care with a focused mission: To offer surgeons better options for treating millions of patients worldwide who suffer from painful disc herniations that cause sciatica and low back pain. Under the direction and guidance of an experienced management team and a world-class scientific advisory board made up of renowned clinicians from around the world, Intrinsic Therapeutics has developed the novel and patented Barricaid device that has demonstrated improved patient outcomes in multiple peer-reviewed articles.
Cary P. Hagan, CEO
Intrinsic Therapeutics, Inc.
+1 781 932-0222
SOURCE Intrinsic Therapeutics