For Biologic Vertebral Augmentation of osteoporotic compression fractures
The OptiMesh 1500DS Deployable Surgical Mesh is a Polyethelene Terephthalate (PET) mesh pouch designed to contain impacted granular bone graft and enable its incorporation. The OptiMesh DS system provides a contained biologic alternative to PMMA-based procedures for the percutaneous treatment of intravertebral pathologies, most commonly osteoporotic compression fractures.
In OptiMesh DS cases, the damaged vertebra is approached unilaterally and a cavity is prepared in the center. The OptiMesh DS implant is then inserted empty and packed in situ with bone graft. As more graft is impacted into the mesh, the increasing volume of graft deploys the mesh and generates significant distraction force. If the fracture is mobile, this distractive force commonly results in restoration of vertebral body height. Then, when completely filled, the OptiMesh implant fibers become taut and granular mechanics transforms the contained graft into a custom-fit, rigid, load-bearing graft pack.
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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.
OptiMesh 1500DS Case 2
84yr old F T12, L1, L2 compression fracture. patient reported good immediate and lasting pain relief. 3yr CT shows good incorporation of graft.
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.
OptiMesh 1500DS Case 1
Case 1 – 69yr old F T7&8 compression fracture, post-op and 3year ct’s. Patient reported immediate and lasting pain relief. 3yr CT shows good incorporation of graft.
