SeaSpine marked the milestone implantation of the 50,000th NanoMetalene® interbody device. This is an increase from the 25,000th NanoMetalene implant, in 2019.
NanoMetalene is a proprietary surface technology for interbody implants that incorporates a sub-micron layer of commercially pure titanium that is molecularly bonded to a PEEK implant using a high-energy, low-temperature atomic fusion deposition process. It is designed to provide a bone-friendly titanium surface with 360 degree coverage, while retaining the benefits associated with traditional PEEK implants such as biocompatibility, a modulus of elasticity similar to bone and excellent radiographic visibility for postoperative imaging.
In 2020, the company received an amended FDA 510(k) clearance to describe the surface technology as “providing a microscopic roughened surface with nano-scale features." This amended indications for use across the 12 implant systems to which NanoMetalene has been applied.
Dennis Cirino, Senior Vice President of Global Spinal Systems, said, “In just over two years, we more than doubled the number of NanoMetalene implants used in surgery. ...SeaSpine remains committed to advancing the development of differentiated surface materials and novel designs, highlighted by the introduction of Reef Topography™ and the WaveForm 3D implant portfolio. The success of our NanoMetalene interbody portfolio demonstrates that leveraging science and clinical data is instrumental in driving the optimization of fusion postoperatively.”