FDA clears Medtronic’s expanded indications of Vertex reconstruction system

16 February 2015 (Last Updated February 16th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted clearance for Irish medical technology firm Medtronic's expanded indications of the Vertex Reconstruction System.

The US Food and Drug Administration (FDA) has granted clearance for Irish medical technology firm Medtronic's expanded indications of the Vertex Reconstruction System.

Approval for the Vertex family of products enables lateral mass and pedicle screws to be used as a form of fixation for the treatment of several pathologies occurring in the posterior cervical spine, allowing FDA-cleared systems available in the US for use of screws at C1-C7.

The Vertex Reconstruction System comprises implants and instruments, designed to surgically treat patients with different conditions that can contribute to spinal instability, including degenerative disease, fracture, tumours and/or deformity.

Surgeons can perform a procedure called spinal fusion to relieve the pain and other symptoms often associated with these conditions.

The procedure involves placing bone graft material between the treated vertebrae so they will fuse, or join together, with the goal of restoring spinal stability.

"The Vertex Reconstruction System comprises implants and instruments, designed to surgically treat patients with different conditions that can contribute to spinal instability, including degenerative disease, fracture, tumours and/or deformity."

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

RUSH University neurosurgeon Dr Vincent Traynelis said: "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.

"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 provides surgeons adjustability in their treatment options through multiple plate designs, rods, screws, and hooks, when paired with the Vertex Occipitocervical Module.

Medtronic president of the Spinal business and senior vice-president Doug King said: "Medtronic can now partner with physicians and professional spine societies to provide the most productive educational experiences to further understand, and enhance the various techniques for treating conditions in the posterior cervical spine."

The Vertex system was designed to offer immobilisation and stabilisation of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3.