FDA Expands Indication for Medtronic’s Vertex Spine System

Medtronic plc received clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its Vertex reconstruction system. The new clearance for the Vertex family of products allows for lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine, making it one of the first FDA-cleared systems available in the United States for use of screws at C1-C7, according to Medtronic.

“Broadening the Vertex reconstruction system’s indication beyond current upper thoracic screw fixation displays Medtronic’s commitment to provide surgeons with the most innovative and effective surgical treatment options with the goal of improved patient care,” said Vincent Traynelis, M.D., neurosurgeon at Rush University in Chicago, Ill. “This clearance opens up new opportunities for collaboration with medical device companies such as Medtronic to create a sound foundation on which we can advance current techniques, create new solutions, and deliver the next level of care to our patients.”

The Vertex system consists of implants and instruments that can be used to surgically treat patients with a variety of conditions that can contribute to spinal instability, including degenerative disease, fracture, tumors, and/or deformity. To relieve the pain and other symptoms often associated with these conditions, surgeons perform a spinal fusion, which involves placing bone graft material between the treated vertebrae so they will fuse, or join together, with the goal of restoring spinal stability.

Surgeons will place titanium rods, screws, hooks, and/or other connecting components in the appropriate anatomical structures to provide internal stabilization to the posterior cervical spine while the fusion of vertebrae occurs.

According to Medtronic, when paired with the Vertex Occipitocervical Module, the system offers surgeons “adjustability in their treatment options through multiple plate designs, rods, screws, and hooks, enabling them to tailor procedures to each patient’s needs,” according to a recent news release.

“Our commitment to spine surgery goes beyond procedural innovation. As an industry leader, Medtronic is also focused on improving patient care through areas like advocacy for access to needed therapies and world-class medical education,” said Doug King, president of the Medtronic’s spine business. “Medtronic led the way in the pursuit of posterior cervical screw clearance nearly a decade ago, when we applied for and received FDA cervical screw clearance for our Axis fixation system, which became the predicate device for cervical multi-axial screw fixation that we have just obtained.”

Medtronic plc recently moved its headquarters to Dublin, Ireland, following its inversion purchase of Covidien plc. Medtronic’s spine business is based in Memphis, Tenn.