FDA Clears Baxano’s Avance MIS Pedicle Screw System

Raleigh, N.C.-based Baxano Surgical Inc., a medical device company focused on minimally invasive products to treat degenerative conditions of the lumbar spine, has received U.S. Food and Drug Administration 510(k) clearance of its Avance MIS (minimally invasive surgery) pedicle screw system, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. Avance is designed to provide a quick and easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The Avance system will be in limited market release in the second and third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.

“This FDA clearance represents a significant addition to Baxano Surgical’s MIS product portfolio and offers surgeon and hospital customers an additional solution for their lumbar fusion procedures,” said Ken Reali, president and CEO of Baxano Surgical. “Avance will significantly enhance our ability to meet customer needs and gain a stronger foothold in the MIS fusion market.”

“The Avance system provides a truly percutaneous approach designed to minimize tissue trauma and eliminate additional rod insertion incision,” said spine surgeon Sameer Mathur, M.D.

“The scientific engineering used to design Avance lowers the construct’s overall profile, increases intraoperative flexibility and enhances lock down security,” added Nael Shanti, M.D.

Mathur and Shanti are surgeon designers of the Avance system.

The Avance system is intended 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 the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. The Avance system accommodates single level degenerative procedures as well as multi-level, complex pathologies from T1 to S1.