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Baxano Surgical Receives 510(k) Clearance for the Avance MIS Pedicle Screw System

Fri, 04/11/2014 - 9:41am
Globe Newswire

Baxano Surgical, Inc., a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug Administration 510(k) clearance (k133743) of its Avance MIS Pedicle Screw System, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. The innovative design of Avance provides 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," stated 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," stated 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," stated Nael Shanti, M.D. Drs. Mathur and Shanti are surgeon designers of the Avance system.

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