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Ventris Medical was granted FDA 510(k) marketing clearance in the intervertebral disc space for Amplify Synthetic Bone Graft Putty. Amplify represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and comprises 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.
To enhance remodeling potential, 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.
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.
The proprietary polymer blend in Amplify provides a cohesive, moldable 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 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 generational devices that bring excitement to the surgeon community as well as our distribution partners.”
Source: Ventris Medical
Ventris Medical was granted FDA 510(k) marketing clearance in the intervertebral disc space for Amplify Synthetic Bone Graft Putty. Amplify represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and comprises Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide...
Ventris Medical was granted FDA 510(k) marketing clearance in the intervertebral disc space for Amplify Synthetic Bone Graft Putty. Amplify represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and comprises 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.
To enhance remodeling potential, 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.
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.
The proprietary polymer blend in Amplify provides a cohesive, moldable 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 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 generational devices that bring excitement to the surgeon community as well as our distribution partners.”
Source: Ventris Medical
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
