Baxter’s new bone graft gets US nod

October 10, 2018 0 By CH Unnikrishnan

The US FDA has granted approval for the Actifuse Flow Bone Graft Substitute for use in a variety of orthopaedic surgical procedures, said Baxter International Inc.

Actifuse Flow offers accelerated bone growth in a new, easy-to-use, prepackaged delivery syringe for precise placement into small bony voids or gaps in the skeletal system. It comes ready to use with no mixing or preparation involved and maintains its flowable consistency throughout surgery.

The bone graft substitute is delivered directly from a preloaded syringe with the ability to start and stop delivery, making it compatible with open and less invasive surgical techniques and well-suited for filling small bone defects and complex geometries. As the graft substitute resorbs, it is replaced by the patient’s own bone during the body’s healing process.

Actifuse Flow is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bone structure. It is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Baxter expects it to be used in a variety of orthopaedic surgeries in the pelvis, extremities, and posterolateral spine