Thursday, December 22, 2016
Intrinsic Therapeutics, Inc. announced that the filing of its Pre-Market Approval (PMA) application with the Food & Drug Administration (FDA) for the Barricaid® Anular Closure device is complete. Barricaid has been shown to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain.
"Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus," said Professor Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany. "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).
"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."
