Baxter Announces FDA Clearance of Actifuse Flow

Baxter announced U.S. Food and Drug Administration (FDA) clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. As the newest addition to Baxter’s growing osteobiologics surgery portfolio, 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.

Actifuse Flow utilizes the proprietary silicate-substituted technology of Baxter’s Actifuse Bone Graft Substitute, which enhances silicon levels to accelerate bone formation. Actifuse Flow 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 pre-loaded 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. Baxter expects Actifuse Flow to be used in a variety of orthopedic surgeries in the pelvis, extremities, and posterolateral spine.

"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. Actifuse Flow offers that same reliability in an easy-to-use delivery device. I am pleased to count on the science behind Actifuse Flow to accelerate bone formation in my patients," said Robert Norton, MD, an orthopedic spine surgeon serving patients in Boca Raton, Florida.

"As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse Bone Graft Substitute," said Wil Boren, president of Baxter’s Advanced Surgery business. "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."

Actifuse Flow is the latest addition to Baxter’s osteobiologics surgery portfolio, which also includes Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore. These products are based on a proprietary -substituted technology designed to accelerate bone growth and come in varying configurations to accommodate different surgical needs. Baxter expects Actifuse Flow to be available to U.S. customers by year-end. It will be sold in three convenient sizes: 5 mL, 3 mL and 1.5 mL.

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