FDA approves Altapore Bioactive Bone Graft use in posterolateral spinal fusion. Baxter

Baxter International Inc. announced FDA clearance of Altapore Bioactive Bone Graft, a next-generation bioactive and osteoconductive bone graft substitute, for use as an autograft extender in posterolateral spinal fusion. Altapore had previously been cleared for use in orthopedic surgical procedures in the extremities and pelvis.Altapore is designed to enhance bone growth with optimized porosity that promotes earlier vascularization, which plays a central role in the bone formation process by providing oxygen, nutrients, and growth factors critical for bone development. Altapore's porosity also increases cellular activity by providing more surface area for cells to travel along the surface of the graft, which promotes new bone formation. Additionally,Altapore�s unique chemistry contains 0.8 percent silicon by weight, which was shown to be optimal for bone formation in preclinical studies.

Altapore has been formulated to meet surgeons� needs, as it is easy to store, handle and implant. Its precise handling characteristics allow the putty to be molded into multiple shapes to adapt to various surgical needs. Additionally, in a pre-clinical posterolateral spinal fusion model, Altapore used as an autograft extender exhibited similar fusion rates to iliac crest autograft, which is considered the current standard of care in spine surgical techniques. The iliac crest is an area of the pelvis commonly used for acquiring autogenous bone graft.