Spineology completed enrollment of 102 subjects in SCOUT, the Spineology Clinical Outcomes Trial, conducted under an Investigational Device Exemption. The prospective, multi-center, non-randomized study will investigate use of the OptiMesh® deployable graft containment implant in instrumented lumbar interbody fusion.
The porous OptiMesh implant deploys inside of the disc and, as it’s filled with graft, conforms to vertebral body endplates.
The device’s original 2003 FDA 510(k) clearance supported graft containment inside the vertebral body. Data from SCOUT will support the submission of a De Novo application to FDA for expanded indications, allowing use with bone graft and supplemental posterior fixation in lumbar interbody fusion.
Spineology completed enrollment of 102 subjects in SCOUT, the Spineology Clinical Outcomes Trial, conducted under an Investigational Device Exemption. The prospective, multi-center, non-randomized study will investigate use of the OptiMesh® deployable graft containment implant in instrumented lumbar interbody fusion.
The porous OptiMesh...
Spineology completed enrollment of 102 subjects in SCOUT, the Spineology Clinical Outcomes Trial, conducted under an Investigational Device Exemption. The prospective, multi-center, non-randomized study will investigate use of the OptiMesh® deployable graft containment implant in instrumented lumbar interbody fusion.
The porous OptiMesh implant deploys inside of the disc and, as it’s filled with graft, conforms to vertebral body endplates.
The device’s original 2003 FDA 510(k) clearance supported graft containment inside the vertebral body. Data from SCOUT will support the submission of a De Novo application to FDA for expanded indications, allowing use with bone graft and supplemental posterior fixation in lumbar interbody fusion.
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