Ventris Medical's Backpack Receives FDA 510(k) Clearance for Orthopedic and Spinal Fusion Procedures
核心洞察
Ventris Medical (搜索)'s Backpack, a porous biologic scaffold, has received FDA 510(k) clearance for orthopedic and spinal fusion applications, enhancing bone formation and cell proliferation.
Backpack AF utilizes a collagen mesh pouch prefilled with osteoinductive Allocell AF (搜索) allograft fibers, promoting bone remodeling through a 100% biologic graft system.
Backpack AMP incorporates surface-activated Amplify (搜索) granules within a collagen mesh, featuring a bimodal dissolution profile to support fusion site healing and bone remodeling.
Ventris Medical (搜索) has secured FDA 510(k) clearance for its Backpack (Porous Biologic Scaffold, K240765), a novel device intended for use in orthopedic and spinal fusion procedures. The Backpack system is designed to optimize bone formation and cell proliferation, potentially improving outcomes in patients requiring bone grafting.
The Backpack is available in two distinct versions: Backpack AF and Backpack AMP. Backpack AF features a collagen mesh pouch prefilled with osteoinductive Allocell AF (搜索) allograft fibers. This configuration creates a 100% biologic graft system where both the containment pouch and the allograft fibers actively participate in the bone remodeling process at the graft site. The scaffold-like design of the Allocell AF allograft fill facilitates bone cell attachment and proliferation, supporting the natural healing process and promoting stem cell differentiation into bone-forming cells.
Backpack AMP, the second version, incorporates surface-activated Amplify (搜索) granules within the collagen mesh pouch. These granules are composed of two HA-to-βTCP blends exhibiting varying resorption rates. This bimodal dissolution profile provides support to the fusion site during the early stages of healing and continues to aid bone remodeling throughout the fusion process. Both versions are supplied in a ported pouch designed for easy hydration and immediate use, aiming to streamline the surgical workflow.
According to Ventris Medical (搜索) CEO Russell Cook, "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."
Ventris Medical (搜索) focuses on tissue regeneration and orthobiologics, aiming to provide innovative solutions for bone grafting and related procedures. The FDA clearance of the Backpack system represents a significant milestone for the company and potentially offers surgeons a new tool for enhancing bone fusion and regeneration.