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

Ventris Medical was granted FDA 510(k) clearance to market the Backpack Porous Biologic Scaffold.

Backpack represents a new class of biomaterials designed to optimize cell proliferation and bone formation. It is used in orthopedic and spinal fusion procedures. Backpack is available in two versions. One consists of a collagen mesh pouch prefilled with osteoinductive Allocell AF fibers, and the second consists of a collagen mesh pouch prefilled with surface-activated Amplify granules.

Backpack AF Prefilled 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 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.

Backpack AMP Prefilled 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-BTCP 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.

Russell Cook, CEO of Ventris Medical, commented, “We are very pleased to receive FDA clearance for both the Backpack AF and Backpack AMP Bone Graft Systems. 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