Baxter wins FDA nod for Actifuse Flow bone graft substitute

Baxter (NYSE:BAX) said today it won FDA clearance for its Actifuse Flow bone graft substitute, indicated for use in a variety of orthopedic surgical procedures.

The Actifuse Flow graft uses proprietary silicate-substituted technology from the Deerfield, Ill.-based company’s Actifuse bone graft substitute, intended to enhance silicon levels to accelerate bone formation. The newly cleared graft requires no mixing or preparation and is designed to maintain a flowable consistency throughout surgical procedures, the company 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. 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,” orthopedic spinal surgeon Dr. Robert Norton said in a prepared statement.

Baxter said that the Actifuse Flow is pre-loaded into a syringe and is designed to be resorbed and replaced by the patient’s own bone during the body healing process. The company plans to offer it in 5 mL, 3 mL and 1.5 mL sizes.

“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,” Baxter advanced surgery biz prez Wil Boren said in a press release.

In July, Baxter saw shares fall slightly despite the medical giant beating expectations on Wall Street with its second quarter earnings results.

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