VySpine’s UniVy OsteoVy-Ti NanoVy-HA cervical IBF system gets FDA clearance

2023-04-26

上市批准临床申请

The implant is indicated for intervertebral body fusion to be used at one level in the cervical spine, from C3 to T1 FDA gives clearance to VySpine’s UniVy OsteoVy-Ti NanoVy-HA cervical IBF system. (Credit: The U.S. Food and Drug Administration/Wikimedia Commons) VySpine has been given the 510(k) clearance from the US Food and Drug Administration (FDA) for its UniVy OsteoVy-Ti NanoVy-HA cervical IBF system for the treatment of degenerative disc disease (DDD). According to the spine company, the implant is indicated for intervertebral body fusion to be used at one level in the cervical spine, from C3 to T1. The UniVy OsteoVy-Ti NanoVy-HA cervical IBF system features the NanoVy-HA technology of VySpine in partnership with Promimic. NanoVy-HA is a procedure in which the 3D-printed UniVy OsteoVy-Ti implant gets surface-treated using hydroxyapatite. The typical coating thickness is 50 micrometers thick, whereas NanoVy-HA’s surface treatment can be only 20 nanometers in thickness, said VySpine. The spine company stated that the NanoVy-HA technology has been designed to enhance bone integration and improve the quality of the all-around area of the implant. The NanoVy-HA coating pierces the porous structure of the UniVy OsteoVy implant. VySpine claimed that the combination of high wettability and optimal surface chemistry of NanoVy-HA with nano-roughness that is optimised, mediates bioactivity and adsorption of the specific protein to the implant. These properties regulate the behaviour of cells and impact the process of regeneration of tissues by enhancing osteoblast’s functions, which allows for the creation of more bone quicker. The UniVy OsteoVy-Ti NanoVy-HA cervical IBF system is said to have optimal dimensions and structure of the pore. It is available in a variety of footprints to suit nearly every cervical interbody technique. Furthermore, the implant is claimed to come in a variety of sizes, heights, as well as lordotic angles. Earlier this year, VySpine secured FDA’s 510(k) clearance for its LumiVy NanoVy Ti Lumbar IBF system. The implant was indicated for intervertebral body fusion for use at one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease with up to Grade 1 spondylolisthesis.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构