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The STAR RF Ablation System is intended for ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The subject device (STAR RF Ablation System) is a bipolar, high frequency electrosurgical system comprising the SpineSTAR Ablation Instrument, MetaSTAR RF Generator, AE Cable, Hand Switch Cable, StabiliT Introducer and PowerCURVE Navigational Osteotome. The subject device is intended to produce lesions by direct application of radiofrequency currents for the relief of chronic low back pain by basivertebral nerve ablation. The MetaSTAR RF Generator applies radiofrequency (RF) energy into the SpineSTAR. StabiliT Introducer is used to create access to the vertebral body and PowerCURVE Navigational Osteotome is used to create a channel to the target site for ablation. During lesion creation, targeted tissue in vertebral body is exposed to RF energy. The application of RF energy causes a thermal reaction at the targeted tissue site to ablate the basivertebral nerve. When used as directed, the SpineSTAR Ablation Instrument is connected to the AE Cable, which is connected to MetaSTAR. A Hand Switch Cable is connected to MetaSTAR to control delivery of RF energy to the target tissue. MetaSTAR monitors the temperature at the periphery of the ablation zone to enable controlled ablation.

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