Intrinsic Therapeutics, a developer of lumbar spine anulus closure devices, has enrolled the 400th patient in level 1, a randomized trial of its Barricaid device.
The study is being conducted in Germany, Switzerland, Austria, and The Benelux to demonstrate fewer disc reherniations and improved function in high-risk patients treated with the Barricaid compared to limited discectomy only.
The surgery was performed by Dr Frederic Martens in Aalst, Belgium.
Barricaid device is engineered to close the hole in the anulus in order to prevent future leaks and to re-establish pressure within the disc.
The unique characteristics of the device allow the surgeon to quickly and securely close defects in the anulus as an adjunct to standard micro-discectomy.
The act of closing the anular defect reduces the risk of reherniation, preserves the internal pressure, and provides the opportunity to maintain disc height.
Intrinsic COO Jacob Einhorn noted with 21 centers involved in the trial, the company believes that this is the largest and most comprehensive study ever performed to investigate the effects of discectomy in the lumbar spine.
"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," Einhorn added.
The information gathered from the trial will also allow correlation analyses of a multitude of clinical variables that have never before been possible.