Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Actifuse Flow bone graft substitute.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The Actifuse Flow bone graft substitute can be used in a range of orthopedic surgical procedures such as pelvis, extremities, and posterolateral spine.
It can also be used in posterolateral spinal fusion procedures with appropriate stabilizing hardware.
The substitute will be available in three sizes, including 5mL, 3mL and 1.5mL. The company plans to make the product available to the customers by the end of this year.
Baxter’s advanced surgery business president Wil Boren said: “As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse Bone Graft Substitute.
“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.”
Part of the osteobiologics surgery portfolio, Actifuse Flow is said to provide accelerated bone growth in a new and prepackaged delivery syringe for precise placement into small bony voids or gaps in the skeletal system.
The new bone graft substitute uses silicate-substituted technology of the firm’s Actifuse bone graft substitute, to optimize silicon levels for enhancement of bone formation.
Actifuse Flow is delivered directly from a pre-loaded syringe that holds capacity to start and stop delivery, making it compatible with open and less invasive surgical techniques and suitable for filling small bone defects and complex geometries.
While the graft substitute resorbs, it is replaced by the patient’s own bone during the body’s healing process.
Florida’s orthopedic spine surgeon Dr Robert Norton said: “Baxter’s Actifuse Bone Graft Substitute has been demonstrated in preclinical models to show greater new normalized bone volumes over other available bone graft substitutes. As the graft resorbs into the body, it is replaced by natural bone during the healing process.”
Baxter’s osteobiologics surgery portfolio is also comprised of Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore.
The products, which promote bone growth, are available in different configurations to accommodate various surgical needs.