Ventris Medical, a privately held orthobiologics and tissue regeneration company, said the FDA has granted 510(k) clearance for Backpack (Porous Biologic Scaffold, K250556) for use in the Intervertebral Disc Space. Backpack represents a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. It's available in 2 versions: One version consists of a collagen mesh pouch filled with our osteoinductive Allocell AF fibers, and second version consists of a collagen mesh pouch filled with surface activated granules.
In the first format, the osteoinductive allograft fibers are completely enclosed inside a collagen mesh pouch. The company said the 100% biologic graft system is the first of its kind in that both the containment pouch and allograft fibers contribute 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 the second 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.
