Ventris Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its synthetic bone graft putty, Amplify.
This clearance allows the use of Amplify in the intervertebral disc space. It is claimed to be a new class of synthetic biomaterials designed to optimise cell proliferation and bone formation.
It consists of biphasic ceramic granules (HA/βTCP) suspended in an alkylene oxide polymer carrier.
The device is designed to be used standalone or along with autograft bone in a 1:1 ratio as a bone graft extender.
The granules in Amplify undergo a patented surface activation process to enhance remodelling potential.
This process creates a network of polygonal microfilaments that extend from the granule surface, acting as a bio-instructive vector to entrap healing elements and guide cellular processes.
The activation increases surface area, porosity, and dissolution rate, which in turn promotes cellular attachment, proliferation, and remodelling.
Amplify's mineral component is a hybrid mixture of surface-activated biphasic granules with two distinct HA-to-βTCP blends that resorb at different rates.
These granules, with ratios of 20/80 and 60/40, offer a bimodal dissolution profile that supports both early healing and progressive bone remodelling.
The polymer blend in the device offers a cohesive, mouldable matrix that enables accurate graft placement and containment at the defect site.
This polymer is resorbed into the surrounding tissues post-implantation, allowing the activated biphasic granules to exert their healing effects immediately.
Ventris Medical CEO Russell Cook said: “We are very pleased to receive FDA clearance for the Amplify synthetic bone graft putty for the intervertebral disc space. This technology combines two heavily studied biphasic mineral components, which are surface-activated through our patented process and suspended in our proprietary polymer carrier.
“In a market crowded with a plethora of commodity offerings, our company mission is to develop next-generation devices that bring excitement to the surgeon community, as well as our distribution partners.”
