Ventris Medical Gains 510(k) Clearance for Amplify Bone Graft Putty

The U.S. Food Food and Drug Administration has granted 510(k) clearance to Ventris Medical for its Amplify Synthetic Bone Graft Putty for use in the intervertebral disc space. The synthetic biomaterial was developed for the optimization of cell proliferation and bone formation. It contains biphasic ceramic granules suspended in an alkylene oxide polymer carrier and can be used alone or with autograft bone.
 
“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,” said Russell Cook, CEO of Ventris Medical.
 
The surface-activated granules create an encompassing network of polygonal microfilaments that extend from the granule surface, which acts like a bio-instructive vector that can entrap critical healing elements and guide cellular processes.
 
The mineral component comprises a hybrid mixture of surface-activated biphasic granules composed of two distinct HA-to-βTCP blends that resorb at different rates.
 
The polymer blend 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.
 
“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 synchronized 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,” explained John Brunelle, Ph.D., COO.