Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nanotechnology designation of its neoWave™ line of interbody fusion implants featuring proprietary NANOACTIV surface technology.
The nanotechnology designation enhances claims for the neoWave cervical and lumbar interbody devices with NANOACTIV surface, of which over 7,000 have been implanted in the United States.
The NANOACTIV micro and nano-roughened surface is designed to improve fixation to adjacent bone, and has been engineered with nano-scale surface features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by differentiation of human mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix in vitro, as compared to an untreated surface. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
The structurally advanced neoWave interbody technology consists of a patented 3D-printed lattice design that retains strength and reduced device stiffness without the use of traditional implant framework or solid walls. The neoWave matrix has been shown to increase endplate contact surface area and resistance to subsidence compared to a similar device containing solid framework and/or traditional anti-migration teeth*.
Ryan Phillips, President of Xēnix Medical, commented, “Receiving nanotechnology clearance for the neoWave interbody systems is an incredible milestone and achievement for Xēnix, elevating the neoWave implant systems into a distinct device category shared only by a few companies in the industry. As we actively develop a complete line of neoWave interbody devices, the NANOACTIV surface will be a dominant enhancement of future implant systems.
The unique combination of a nanotechnology surface and completely latticed implant presents a significant breakthrough in treating patients that require interbody fusion. We believe this designation evidences the potential benefit of nanotechnology to patient outcomes and improving care.