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Intrinsic Therapeutics Announces Enrollment of 300th Patient in Barricaid® Randomized Trial
By: PR Newswire
Dec. 3, 2012 02:01 AM
WOBURN, Massachusetts, Dec. 3, 2012 /PRNewswire/ -- Intrinsic Therapeutics, a Medical Device Spine company, today announced a key milestone in a clinical study of its Barricaid® Prosthesis: 300 patients are now enrolled in a prospective, randomized, multi-center trial to definitively establish the safety and effectiveness of the implant. This Level 1 controlled study is being conducted across five countries in Europe and is expected to include 400-650 patients.
"We believe this is the most comprehensive study ever performed on lumbar discectomy and are very encouraged by the progress thus far," said Dr. Frederic Martens, Principal Investigator from OLV Hospital in Aalst, BE. "We are excited to be a part of this groundbreaking trial and look forward to the enrollment of the 400th patient in April," added Co-Investigator, Dr. Geoffrey Lesage.
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, Intrinsic 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. The positive clinical and commercial results observed in previous studies, soon to be presented at the Annual Congress of the German Spine Society (DWG) in Stuttgart, Germany, provide an increased level of excitement for the final results of this study."
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