US-based tissue regeneration company Ventris Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its new bone graft containment system, Backpack.
Backpack, also known as Porous Biologic Scaffold K240765, is an advanced biomaterial designed for the optimisation of cell proliferation and bone formation.
Intended for use in orthopaedic and spinal fusion procedures, the new bone graft containment system is offered in two versions.
The first version comes with a collagen mesh pouch prefilled with the company’s osteo-inductive Allocell AF fibres, and the second with its surface activated Amplify granules.
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 2 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.
“Our company mission is to continue to develop next-generation devices that bring excitement to the surgeon community as well as our distribution partners.”
The Backpack AF format comes with osteoinductive allograft fibres that are completely enclosed inside a collagen mesh pouch, which enables easy hydration.
It is the first 100% biologic graft system featuring a containment pouch and allograft fibres both contributing to the bone remodelling process at the graft site.
With a scaffold-like structure, Allocell AF allograft fill enables bone cells to attach and proliferate, facilitating the natural healing process.
The osteoinductive nature of the Allocell AF fibres actively promotes the differentiation of stem cells into bone-forming cells, enhancing bone regeneration.
In the Backpack AMP format, the surface treated biphasic Amplify granules are completely enclosed inside the collagen mesh pouch.
The hybrid mixture of surface-activated biphasic granules contains two distinct HA-to-βTCP blends that resorb at different rates.
The granules are derived from conventional HA/BTCP granules with a faster resorbing ratio of 20/80 and a moderate resorption ratio of 60/40.
They enable a bimodal dissolution profile that supports the fusion site in the early stages of healing and promotes progressive bone remodelling throughout the fusion process.
Ventris Medical COO John Brunelle said: “The Backpack technology platform is our latest venture in enhancing the surgeon experience and fusion outcomes.
“The sophisticated design of the containment system allows for precise delivery and retention of our clinically validated biphasic granules and allograft fibres, ensuring a more consistent healing response at the fusion site.
“This latest milestone establishes yet another platform for future product developments and further validates Ventris as a key innovator in the orthobiologics space.”
