ProMap EMG Navigation System
Minimally Invasive Spine Surgery or percutaneous spine surgery can greatly reduce surgical morbidity, but may also make it difficult for physicians to safely navigate around neural structures. To enhance surgical safety, physicians have turned to intraoperative neuromonitoring.
The ProMap system includes a blunt-tipped monopolar probe and an exchange cannula. This enables surgeons to percutaneously map nerve root location and then facilitate the quick, safe delivery of sharp guide needles down to the spinal surface.
Product Literature
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ProMap EMG Navigation Probe Labeling
Indications for Use
The disposable pedicle screw probe is used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
For complete listing, see package insert.
OptiMesh Labeling
INTENDED USE / INDICATIONS
OptiMesh is a surgical mesh intended to contain and reinforce bone grafting materials and/or bone graft substitutes in bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These voids or gaps may be surgically created osseous defects, natural gaps, or defects partially surrounded by bone, defects created from traumatic injury, or a combination thereof. Adjunct fixation is recommended in cases involving segmental instability.
OptiMesh is indicated for use in orthopedic grafting procedures, including the following:
Lumbar interbody fusion: The OptiMesh 1500 System is used to contain, enhance the compaction of, and stabilize and reinforce bone graft material used in the intervertebral space of patients undergoing fusion to treat degenerative disc disease at one spinal level from L2-S1. For this use, OptiMesh 1500 is to be used in conjunction with stabilizing posterior fixation.
Thoracolumbar vertebral body fractures: OptiMesh 1500 with allograft is intended for vertebral augmentation, including fracture reduction, for the treatment of painful insufficiency fractures of the vertebral body due to osteoporosis, minor trauma or benign lesions.
It is also intended for the treatment of painful traumatic vertebral fractures which are either a) clinically stable upon presentation, or b) are surgically stabilized with posterior fixation.
For a complete listing, see package insert.
Granular Mechanics
A subspecialty of physics known as Granular Mechanics describes the unique physical characteristics of granular materials.
One useful characteristic of granular materials is their properties change when contained, i.e., flowable (liquid-like) to solid. OptiMesh utilizes this principle.
In an open environment, like the cannulae used to deliver bone into an OptiMesh, the bone granules can flow like a liquid and be pressurized to generate hydraulic-like lifting capabilities. Yet, when a space is enclosed, like the inside of an OptiMesh, the graft granules can be so densely compacted they point load and form force chains, making the graft pack act like a load-bearing solid structure.
