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Baxano Surgical obtains FDA approval for Avance MIS pedicle screw system

Baxano Surgical has obtained the US Food and Drug Administration’s (FDA) 510(k) approval for its Avance minimally invasive pedicle screw system.

The Avance MIS pedicle screw system has been designed for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for indications including degenerative disc disease and spondylolisthesis.

The indications also include trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.

Baxano Surgical’s Avance system addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The system accommodates single level degenerative procedures and also multi-level, complex pathologies from T1 to S1.

The Avance MIS pedicle screw system has been designed by Dr Nael Shanti and Dr Sameer Mathur.

Dr Mathur noted that the Avance system provides a truly percutaneous approach designed to minimize tissue trauma and eliminate additional rod insertion incision.

"The scientific engineering used to design Avance lowers the construct’s overall profile, increases intraoperative flexibility and enhances lock down security," Dr Mathur added.

Baxano Surgical will initially launch the Avance system in limited markets in the second and third quarter of 2014. The company plans to fully launch the device in the fourth quarter of 2014.