Surgical control of materials like PMMA (bone cement) can be challenging for doctors. Intraosseous porosity and fractures can lead to a loss of containment and allow PMMA extravasation.
The OptiMesh 500E series mesh is designed to enhance the control of PMMA in procedures such as Vertebral Augmentation for osteoporotic compression fractures.
The OptiMesh 500E mesh has a very tight pore structure to help control PMMA flow.
Features:
- Constructed of multi-strand Polyethelene Terephthalate (PET) thread
- Deployable for minimally invasive implantation
- Supplied on an easy-to-handle metal tip that can release the mesh percutaneously
- Radiolucent for ease of intraoperative PMMA imaging
- 500E micron nominal pore size (.5mm) provides low surface porosity to restrict PMMA flow
Product Labeling
OptiMesh Product Labeling
This product has not been cleared by the FDA for use in the US for the indication shown here.
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.
