Kitrosser

I.

FACTUAL AND PROCEDURAL BACKGROUND1

A. NuVasive and the NeuroVision Device

Included among NuVasive's spine surgery products is the NeuroVision device,

which is designed to sense the presence of nerve tissue during surgery, including when a

surgeon accesses the spine or places instrumentation in the spinal vertebrae. NuVasive

markets the NeuroVision device as, among other things, an aid to a specific type of spine

surgery where the surgeon accesses the spine from the patient's side, rather than from the

patient's back or front as is traditionally done. NuVasive has copyrighted and

trademarked the moniker "XLIF" (an acronym for "eXtreme Lateral Interbody Fusion")

for this type of surgery. A recognized risk of this procedure is injury to the nerves of the

psoas muscle, which the surgeon must pass through in order to access the spine from the

patient's side. NuVasive claims the NeuroVision device can assist the surgeon in

avoiding injury to these nerves during surgery. Tens of thousands of patients have

undergone surgery using the NeuroVision device.

NuVasive created two pamphlets about the NeuroVision device that NuVasive

encouraged surgeons…