Ventris Medical today announced that the FDA has granted 510(k) clearance for Backpack, a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. Backpack is available in two versions: One version consists of a collagen mesh pouch prefilled with osteoinductive Allocell AF fibers and in the second version, the collagen mesh pouch is prefilled with surface activated Amplify granules.
In this format, the osteoinductive allograft fibers are completely enclosed inside a collagen mesh pouch. The 100% biologic graft system features both the containment pouch and allograft fibers contributing to the bone remodeling process at the graft site. The Allocell AF allograft fill has a scaffold-like structure, enabling bone cells to attach and proliferate, which helps facilitate the natural healing process. The osteoinductive nature of the Allocell AF fibers actively promote the differentiation of stem cells into bone-forming cells, which enhances bone regeneration. Backpack AF is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.
In this format, the surface treated biphasic Amplify granules are completely enclosed inside the collagen mesh pouch. The hybrid mixture of surface-activated biphasic granules are composed of two distinct HA-to-βTCP blends that resorb at different rates. These surface-activated granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption), resulting in a bimodal dissolution profile that nourishes the fusion site in the early stages of healing and supports progressive bone remodeling throughout the fusion process. Backpack AMP is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.
