Medtronic's Vertex Reconstruction System approved for cranial stabilization

By E. Janene Geiss

Philadelphia, Nov. 29 - Medtronic, Inc. announced Tuesday that its previously released Vertex Reconstruction System is now indicated for use in cranial stabilization.

Vertex consists of occipitocervical plate/rods, screws, hooks and other connecting components intended to provide stabilization to promote fusion of the occipitocervical spine, cervical spine and the upper thoracic spine, according to a company news release.

The system is indicated for use in cases of degenerative disc disease, spinal stenosis (narrowing of the spinal canal), spondylolithesis (forward shifting of vertebra position), fracture, dislocation, tumors and failed previous fusions, officials said.

In the surgical procedure, a surgeon enters through the back of a patient's neck and uses titanium rods, multi-axial screws and hooks of the Vertex system to stabilize a patient's head with the neck. The stabilization helps encourage fusion, officials said.

The system originally received 510(k) clearance from the U.S. Food and Drug Administration for laminar hook placement on the C1 - T3 vertebrae and for pedicle screw use on the T1 - T3 vertebrae. The occipitocervical clearance was granted in September 2005.

Medtronic Sofamor Danek is a Memphis, Tenn., developer of spine therapeutics to treat spinal disorders.

Medtronic, Inc. is based in Minneapolis and focuses on development of medical technology to alleviate pain, restore health and extending life for people around the world.

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