FDA clears Baxter’s prepackaged synthetic bone filler graft | Digital Science

Baxter International received an clearance for a new formulation of its Actifuse synthetic bone substitute, now deliverable via a syringe that requires no mixing or preparation.

For use in a variety of orthopedic surgeries, Actifuse Flow uses the same silicate-substitution to help accelerate bone formation after being placed in small voids or gaps in the skeletal system.

The latest addition to Baxter’s osteobiologics portfolio, it is designed to maintain a flowable consistency throughout surgery. As the graft is resorbed, it is replaced by the patient’s own bone during the healing process.

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In a statement, Baxter said it expects Actifuse Flow to be used in open and less-invasive surgeries in the pelvis, extremities and posterolateral spine, and described it as being well-suited to fill small bone defects and complex geometries.

The Deerfield, Illinois-based company expects Actifuse Flow to be available to U.S. customers by the end of the year, in 5 mL, 3 mL and 1.5 mL sizes. The graft substitute is intended only as a for gaps and voids, and not where it will serve as structural or load-bearing support.

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