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www.fdanews.com/articles/169907-fda-clears-nanofuse-bone-void-filler-for-use-in-spinal-fusions

FDA Clears NanoFuse Bone Void Filler for Use in Spinal Fusions

February 10, 2015

Nanotherapeutics’ NanoFuse demineralized bone matrix received expanded FDA clearance for use during spinal fusion surgery, the company said Tuesday. The bone filler can now be used with transplanted bone from a patient’s own body as a bone graft extender in the posterolateral spine.

The flexible, putty-like NanoFuse DBM is a composite human tissue graft designed to enhance surgical handling, graft stability and bone growth, the company said. It’s activated with sterile fluid and placed in bony voids or gaps in the skeletal system that aren’t essential to skeletal stability.

NanoFuse is the first DBM product to contain bioactive glass, which facilitates rapid bone bonding and formation by remodeling into a recipient’s skeletal system, the devicemaker added. — Kellen Owings