FDA approves Baxano’s Avance minimally invasive pedicle screw system

10 April 2014 (Last Updated April 10th, 2014 18:30)

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

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

Baxano Surgical has designed the Avance MIS pedicle screw system for posterior, non-cervical pedicle fixation of the spine to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion for degenerative disc disease and spondylolisthesis.

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

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

Incorporating innovative design, the Avance Avance MIS pedicle screw 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.

Dr Nael Shanti and Dr Sameer Mathur are the surgeon designers of the Avance system.

Dr Mathur said the system provides a percutaneous approach designed to minimise 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 said.

Baxano Surgical will initially launch the Avance system in limited markets in the second and third quarter of this year, with the company planning to fully launch the device in the fourth quarter.

In March 2014, Baxano Surgical announced $10m private placement of convertible debentures. The company said that it plans to use the proceeds to expand its product portfolio through the development of the Avance pedicle screw system.