Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow

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Baxter International Inc., a global leader in advancing surgical innovation, 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 silicate-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.

Actifuse Flow Bone Graft Substitute Indication

Actifuse Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bone structure. Actifuse Flow 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. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Important Risk Information for Actifuse Flow Bone Graft Substitute

Actifuse Flow is contraindicated where the device is intended as structural/load-bearing support in the skeleton system. Actifuse Flow bone graft substitute has not been cleared for vertebroplasty.

Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.

The effect of mixing Actifuse Flow with substances other than sterile saline/water, autologous blood or bone marrow aspirate is unknown.


For Further Information

More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials. This report covers the following market segments: bone graft substitutes (which is represented by allografts, demineralized bone matrix, and synthetic bone grafts), orthopedic growth factors, cellular allografts, orthopedic cell therapy, hyaluronic acid viscosupplementation, orthopedic cartilage repair and spinal machined bone allografts

The iData series on the market for orthopedic biomaterials covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic biomaterials market data or procedure data, register online or email us at for an U.S. Market Report Suite for Orthopedic Biomaterials brochure and synopsis.

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