OptiMesh® Deployable Grafting System

OptiMesh®  is a three-dimensional deployable mesh pouch that's implanted into skeletal defects empty, through a small tube, and then deployed to its full size once it’s in place. This enables doctors to treat skeletal 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.

  

Regardless of the skeletal defect being treated, OptiMesh implantation is the same. A 1500 series OptiMesh in a vertebral defect is depicted below.

intrabody-fig1a

A cavity is created in the defect through a small tube with a proprietary expanding shaping tool

intrabody_fig2a

The mesh is inserted, empty, through the tube

intrabody_fig3a

The mesh is filled and released

 

 

OptiMesh 1500 Series 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.

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.