The FDA expanded its clearance of Baxter International’s Altapore bioactive bone graft substitute to include its use as a supplement to autografts of a patient’s bone in posterolateral spinal fusion surgeries.
The graft is designed to enhance bone growth with a porosity that promotes the formation of blood vessels critical for bone development. The porosity also increases cellular activity by providing more surface area.
In addition, the putty material contains 0.8% silicon by weight, which has been shown to be optimal for bone formation in preclinical studies, Baxter said in a statement. The company has started updating its packaging inventories to carry the new FDA-approved label, and plans to start selling the product in the U.S. by the end of the year.
Altapore, which can be molded into various shapes to meet surgical needs, had previously received FDA clearances for orthopedic procedures in the pelvis and extremities as a standalone graft substitute to fill voids or gaps in bone.
In a preclinical spinal fusion model, Altapore, when used as an autograft extender, showed similar bone fusion rates compared to grafts taken from a patient’s iliac crest at the top of the hip bone, which is commonly used for acquiring bone grafts.
It’s the second recent clearance for Baxter and its bioactive graft substitutes: in early September, the FDA gave the OK to a new formulation of the company’s Actifuse bone filler that allows it to be delivered through a prepackaged syringe requiring no mixing or preparation.
After filling small voids and gaps in the skeletal system, it is replaced by the patient’s own bone during the healing process as the graft is resorbed.