New System Improves Fixation in Spinal Fusion Cases

Minneapolis - Medtronic, Inc. announced U.S. market availability of the VERTEX(R) MAX Reconstruction System. This system of multi-axial screws, rods, hooks and connecting components assists in stabilizing the cervical and upper thoracic spine during spinal fusion surgery.

The VERTEX MAX Reconstruction 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.

In the surgical procedure, a surgeon enters through the back of the patient's neck and uses the titanium rods, multi-axial screws and hooks of the VERTEX MAX Reconstruction System to stabilize the cervical and upper thoracic spine. The stabilization helps encourage fusion.

To facilitate use by surgeons, the VERTEX MAX Reconstruction System features top-loading screws with greater flexibility in screw placement, self-tapping screws that eliminate an operational procedural step, rotating saddles that reduce rod contouring and color-coded instrumentation that corresponds with the appropriate implant.

"VERTEX MAX provides increased angulation at the screw-head interface which makes it simpler for me to place screws in situations where a steep trajectory is required," said Dr. Langston Holly, a neurosurgeon at UCLA Medical Center in Los Angeles. "The threaded rods allowed me to use large thoracic pedicle screws while smoothly transitioning into the standard size cervical instrumentation. This system made a very difficult case much easier for me."

"The VERTEX MAX system works very well," said Dr. Praveen Mummanemi, a neurosurgeon at Emory University Hospital in Atlanta. "I have used the system to instrument all levels in the cervical region and upper thoracic spine. Its versatility and ease of use make it suitable for all of my posterior fixation needs in these areas."

The VERTEX MAX Reconstruction System received 510(k) clearance from the U.S. Food and Drug Administration in Dec. 2004 for laminar hook placement on the C1 - T3 vertebrae and for pedicle screw use on the T1 - T3 vertebrae. This system is intended for posterior use only.

SOURCE: Medtronic