FDA Expands NanoFUSE® DBM Clearance to Include Spinal Fusion

Nanotherapeutics, Inc., says its proprietary bone void filler product, NanoFUSE® DBM (demineralized bone matrix), has received expanded U.S. FDA 510(k) marketing clearance for use in spinal fusion surgery. The product can now be used with autograft material as a bone graft extender in the posterolateral spine.

Background

NanoFUSE® DBM is a novel composite allograft, expressly designed to optimize surgical handling performance, graft stability, and (a new phrase to us) osteoproductivity. It is the first off-the-shelf DBM product containing bioactive glass to be made available for use in an orthopedic clinical setting. As an adjuvant to DBM, bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis. Nanotherapeutics points to the combined properties of DBM and bioactive glass, which it says come together to create a highly favorable environment for bone fusion, as it remodels into the recipient’s skeletal system.

NanoFUSE® DBM is formulated so that it reconstitutes into a paste upon addition of a sterile fluid, such as saline, water for injection and/or autologous blood. The product is supplied as a pyrogen-free implant, in a sterile, single-use, pre-filled syringe, immediately ready for reconstitution.

The malleable, putty-like NanoFUSE® DBM is placed by the surgeon into bony voids or gaps within the skeletal system that are not intrinsic to the stability of the bony structure. These may include the extremities, pelvis and, as a bone graft extender, posterolateral spine. These gaps may be surgically created osseous defects or a result of prior traumatic injury.

Source: Business Wire

 

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