Irish medical technology firm Medtronic has obtained approval from the US Food and Drug Administration (FDA) for expanded indications of the Vertex Reconstruction System.
The expanded approval for Vertex product portfolio enables lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine, allowing FDA-cleared systems for use of screws at C1-C7, in the US.
Medtronic senior vice-president and spinal business president Doug King said: "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."
The Vertex Reconstruction System comprises implants and instruments, which can be used to surgically treat patients with different conditions that can contribute to spinal instability, including degenerative disease, fracture, tumors, and/or deformity.
The Vertex system has been developed to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3.
It is being used for traumatic spinal fractures and traumatic dislocations, tumors involving the cervical spine and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
In addition, it is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The system provides surgeons adjustability in their treatment options through multiple plate designs, rods, screws, and hooks, when paired with the Vertex Occipitocervical Module.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.