Providence Medical Technology commenced enrollment in a human clinical Investigational Device Exemption (IDE) study evaluating safety and effectiveness of the Posterior Cervical Stabilization System (PCSS) in patients with 3-level degenerative disc disease (DDD).
PCSS comprises non-segmental instrumentation with integrated screw fixation to immobilize and stabilize spinal segments. Bilateral facet fixation is achieved at each level by spanning the interspace with points of fixation at each end of the construct.
The FUSE trial is a prospective, multi-center, randomized, controlled study to examine PCSS as an adjunct to posterior cervical fusion with the CORUS Spinal System used with anterior cervical discectomy and fusion (ACDF) to treat multi-level cervical degenerative disease. The study is designed to demonstrate that Circumferential Cervical Fusion achieves superior clinical outcomes vs. ACDF to treat 3-level cervical DDD.
Providence CEO & Co-founder, Jeff Smith, said, "Circumferential stabilization is the standard of care in lumbar fusion, but is rarely performed in the cervical spine due to limitations of existing product offerings. We believe the combination of anterior and posterior cervical fusion with PCSS addresses a significant unmet need and are on a mission to establish CCF as the standard of care for high-risk patients. The FUSE Study is an important next step towards that goal, and we are grateful for the support and dedication of our clinical investigators."