Ventris Medical has announced that the US Food and Drug Administration (FDA) has granted it 510(k) clearance for its synthetic bone graft putty, Amplify.
Amplify is a synthetic biomaterials designed for the optimisation 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.
According to Ventris Medical, in order to enhance remodelling 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 remodelling, the company adds.
The mineral component in Amplify comprises a hybrid mixture of surface-activated biphasic granules composed of two 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, Ventris Medical say, nourishes the fusion site in the early stages of healing and supports progressive bone remodelling throughout the fusion process.
A company press release also states that the proprietary polymer blend in Amplify provides a cohesive, mouldable matrix between the granules that facilitates accurate graft placement and containment at the defect site and can readily be mixed with autograft bone. After implantation, this highly biocompatible polymer resorbs into the surrounding tissues, allowing immediate access to the activated biphasic granules and their healing effects.
Russell Cook, CEO of Ventris Medical, said: “We are very pleased to receive FDA clearance for Amplify synthetic bone graft putty. 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 generational devices that bring excitement to the surgeon community as well as our distribution partners.”
John Brunelle, COO of Ventris Medical, added: “The Amplify technology platform is intended to address critical gaps in current treatment algorithms while bringing greater efficiency to the surgeon experience.
“Our surface-activated granules combine the established clinical efficacy of traditional biphasic materials with state-of-the-art processing techniques, providing a bone graft that is more synchronised with the natural healing process. This milestone sets the stage for future product developments and establishes Ventris as a key innovator in the orthobiologics space.”
