Intrinsic Therapeutics is seeking approval from the US Food & Drug Administration (FDA) for its Barricaid anular closure device.
The company has completed the filing of its pre-market approval (PMA) with the FDA for the Barricaid device.
Barricaid closure device has been designed to prevent repeat disc herniations in patients undergoing back surgery to treat sciatica.
The device is claimed to be the first of its kind to be the subject of a prospective, randomized, and superiority trial involving patients who are at higher risk for revision discectomy surgery to relive recurrent pain resulting from reherniation.
Intrinsic submitted the PMA based on the two-year outcomes of 554 trial participants.
According to the company, the device has been demonstrated to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain.
The firm currently markets the Barricaid in Europe, Australia, the Commonwealth of Independent States, the Middle East and selected countries in other regions across the globe.
Intrinsic president and CEO Cary Hagan said: "We are thrilled to have reached this important milestone and move into the next phase with FDA.
"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."