OptiMesh is a three-dimensional deployable mesh pouch that's implanted into stable vertebral body defects empty, through a small tube, and then deployed to its full size once it’s in place. This enables doctors to treat these defects minimally invasively or even percutaneously.
The principal purpose of OptiMesh is to contain bone graft (1500 series implants) in order to control its placement: Keep the graft where it’s supposed to be; where it was placed.
OptiMesh Product Labeling
Indications for Use:
OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
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The safety and effectiveness of this device used for fusion of the interbody space has not been established. |
Contraindication:
Do not use this device in patients with instability (e.g. resected or collapsed vertebral bodies or fracture of the anterior column). This device does not provide structural support.
For a 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.
