Intrinsic Therapeutics enrolls 400th patient in randomized clinical trial to evaluate effectiveness of Barricaid prosthesis

Intrinsic Therapeutics today announced the enrollment of the 400^th 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."