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Baxter receives FDA clearance for bone graft substitute
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Baxter International Inc. announced FDA clearance for its Actifuse Flow bone graft substitute, which is intended for use in orthopedic surgical procedures.
“As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse bone graft substitute,” Wil Boren, president of Baxter’s advanced surgery business, said in a company press release. “We strive to pioneer products that provide surgeons innovative and dependable tools to help enhance healing, improve outcomes and reduce the total cost of care.”
According to the release, the bone graft substitute provides accelerated bone growth in a pre-packaged delivery syringe for placement into bony voids or gaps in the skeletal system. The Actifuse Flow uses silicate-substituted technology which optimizes silicon levels to accelerate formation of bone. The graft substitute reportedly resorbs and is then replaced by a patient’s own bone during the healing process. Baxter expects the graft to be used in orthopedic surgeries in the pelvis, extremities and posterolateral spine.
Baxter anticipates the Actifuse Flow bone graft substitute to be available in the United States by the end of the year. It will be sold in 5 mL, 3 mL and 1.5 mL sizes.
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