Barricaid Prosthesis Study Enrolls 300th Patient

Three hundred patients have now been enrolled in a Level 1 clinical study that investigators call “the most comprehensive study ever performed on lumbar discectomy.” The study is of the Barricaid Prosthesis made by Intrinsic Therapeutics, Inc., a medical device spine company based in Woburn, Massachusetts. Researchers designed the prospective, randomized, multi-center trial, to establish the safety and effectiveness of the implant. Company officials report that the trial is being conducted across five countries in Europe and they anticipate that it will include 400-650 patients.

The Barricaid device is intended for use with patients who present with primary disc herniation with large annular defects. It is engineered to close the hole in the annulus in order to prevent future leaks and to re-establish pressure within the disc. Company officials say that the Barricaid’s unique characteristics allow the surgeon to quickly and securely close defects in the annulus as an adjunct to standard micro-discectomy.

The closing of the annular defect, they state, reduces the risk of reherniation, preserves the internal pressure, and provides the opportunity to maintain disc height. The market for the Barricaid product—disc herniation, and leg and/or back pain from annular tears—represents the largest segment of the spine market on a procedural basis and the market’s largest unmet need.

The goal of the project is to confirm fewer disc reherniations and improved clinical and radiographic outcomes in patients treated with the Barricaid prosthesis compared to the gold-standard of limited discectomy. The trial has been carefully designed to meet global standards for regulatory and reimbursement requirements.

“We are extremely pleased with our enrollment rate and congratulate our investigators and research coordinators in helping reach this important milestone, ” said Noel Rolon, company vice president, clinical and regulatory affairs. “Successful enrollment of so many patients so quickly indicates both the level of enthusiasm among our investigators and the extraordinary scale of the unmet clinical need associated with disc herniation and discectomy.”

Disc herniations, sciatica, and low back pain result in over 1, 000, 000 surgical procedures annually. These commonly performed discectomy procedures have been documented to result in clinical failure for 25% of all patients, according to Intrinsic Therapeutics officials. The company plans to present the observed clinical and commercial results at the Annual Congress of the German Spine Society (DWG) in Stuttgart, Germany.