The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventris Medical’s Backpack (Porous Biologic Scaffold, K240765) for orthopaedic and spinal fusion procedures.
Designed to optimise bone formation and cell proliferation, the product is available in two versions.
The first version, Backpack AF, features a collagen mesh pouch prefilled with osteoinductive Allocell AF allograft fibres. This ‘100% biologic graft system’ is unique in that both the containment pouch and the allograft fibres actively contribute to the remodelling procedure of the bone at the graft site.
The scaffold-like design of Allocell AF allograft fill allows bone cells to attach and proliferate, aiding the natural healing process. The fibres also ‘promote’ stem cell differentiation into bone-forming cells.
Backpack AMP, the second version, contains surface-activated Amplify granules within the collagen mesh pouch. These granules consist of two HA-to-βTCP blends with various resorption rates, creating a bimodal dissolution profile that supports the fusion site during early healing and continues to aid bone remodelling throughout the fusion process.
Both versions are provisioned in a ported pouch for ‘easy’ hydration and are ready to use, streamlining the surgical workflow.
Ventris Medical CEO Russell Cook said: “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 fibres 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 focuses on tissue regeneration and orthobiologics.
“FDA grants 510(k) clearance to Ventris Medical’s Backpack for orthopaedic use” was originally created and published by Medical Device Network, a GlobalData owned brand.
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