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Ventris Medical Receives 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty

NEWPORT BEACH, Calif., March 13, 2024 /PRNewswire/ -- Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance in the intervertebral disc space for Synthetic Bone Graft Putty (Amplify®). Amplify® represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and is comprised of Amplify® biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used either standalone or in combination with autograft bone (1:1 ratio) as a bone graft extender.

Surface Activated Granules
To enhance remodeling potential, the Amplify® granules undergo a patented surface activation process that creates an encompassing network of polygonal microfilaments that extend from the granule surface. This advanced surface texture acts as a bio-instructive vector that can entrap critical healing elements and guide cellular processes. Activation of the granule surface network increases the surface area, porosity, and dissolution rate of the granules, which creates more bioavailable surface interactions for cellular attachment, proliferation, and remodeling.

Bimodal Dissolution
The mineral component in Amplify® comprises a hybrid mixture of surface-activated biphasic granules 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.

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