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“By simply sealing these large defects, patient outcomes can be improved significantly.” The Barricaid Anular Closure device, designed to prevent repeat disc herniations in patients undergoing back surgery to treat sciatica, is the first of its kind to be the subject of a prospective, randomized, superiority trial involving patients who are at higher risk for revision discectomy surgery to alleviate recurrent pain resulting from reherniation. The PMA submission was based on the 2-year outcomes of 554 trial participants. Inclusion criteria for the study ensured enrollment of only subjects with a high risk of reherniation, subsequent reoperation, and rehospitalization. “Today, quality patient care and the utilization of healthcare resources are scrutinized more than ever,” said Dr. Matthew McGirt, a Neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, North Carolina. “Technologies that demonstrate fewer repeat surgeries when compared to traditional treatment will fit into the paradigm of improving outcomes and conserving healthcare resources.” Further supported by the clinical success demonstrated in earlier single-arm studies, Barricaid today stands alone as a unique treatment device for patients wishing to minimize risk of reherniation and resultant reoperations. Additional benefits include reduction in serious adverse events, episodic pain events and early hospital readmissions (at 30, 60 and 90 days). http://moremilasullivan.denaliinstitute.org/2016/09/29/a-simple-analysis-of-trouble-free-medicine-programs“We are thrilled to have reached this important milestone and move into the next phase with FDA,” said Cary Hagan, Intrinsic’s President and Chief Executive Officer. “Parallel to the PMA approval process, we continue to focus our efforts on market access including reimbursement pathways for this compelling new technology with a sharp focus on delivering a solid Health Economic proposal to payers and hospital systems.” About Intrinsic Therapeutics Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic currently markets and sells the Barricaid in Europe, Australia, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. like thisSee http://www.in-thera.com for more information. Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
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