March 28, 2019

ISASS policy statements highlight evolving evidence and literature in recently published bone graft substitute and vertebral augmentation statements

The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation. The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products. “Bone grafting is an essential part of spinal surgery and ever-evolving science,” concluded the recommendation authors. “With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision.” The authors found: Nonstructural cancellous allograft […]