Ventris Medical Gains Additional 510(k) for Backpack Bone Graft

Ventris Medical was granted FDA 510(k) clearance to market 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.

Backpack is available in two versions. One comprises a collagen mesh pouch filled with osteoinductive Allocell AF fibers; in the second version, the collagen mesh pouch is filled with surface-activated Amplify granules.

Backpack AF with Allocell AF Allograft Fibers

In this format, the osteoinductive allograft fibers are completely enclosed inside a collagen mesh pouch. 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 Allocell AF fibers actively promotes the differentiation of stem cells into bone-forming cells, which enhances bone regeneration.

Backpack AMP with Surface Activated Amplify Granules

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.

Both formats are supplied in a ported pouch for easy hydration and are ready to use, simplifying the surgical process.

Russell Cook, CEO of Ventris Medical, commented, “This graft containment technology is the first of its kind and represents a huge step forward in the bone graft technology available in today’s market. Backpack combines two heavily studied components: osteoinductive allograft fibers and our patented surface activated biphasic mineral components, and places them in a biologic containment system, providing an anti-migration feature not found in any other bone graft offering. Our company mission is to continue to develop next generational devices that bring excitement to the surgeon community as well as our distribution partners.”

Source: Ventris Medical