FDA clears Nvision’s 3D printed PEEK Interbody System
Made using Invibio's PEEK-OPTIMA and Bond3D additive manufacturing technology
The US Food and Drug Administration (FDA) has granted clearance for the first 3D printed PEEK Interbody System made from PEEK-OPTIMA, a polymer from Invibio Biomaterial Solutions, a provider of high-performance biomaterial solutions to medical device manufacturers, made using proprietary Bond3D additive manufacturing technology. The 3D printed PEEK Interbody System from Nvision Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, was co-developed with Invibio Biomaterial Solutions.
The system consists of Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices, each incorporating extensive porous structures that have the potential to promote multi-directional bone ingrowth and improve device fixation, whilst also maintaining PEEK-OPTIMA’s inherent benefits in modulus and imaging.
The use of PEEK-OPTIMA – a material that has already been used in over 15 million implants – offers the benefits of mechanical properties closer to those of bone and also superior imaging capability than titanium implants, the latter allowing surgeons to more accurately monitor fusion progression. Nvision’s 3D printed PEEK Interbody System is a standout in the field of spinal devices as it is the first to combine PEEK-OPTIMA with the design freedom enabled by the Bond3D AM technology to print solid and porous areas for bone ingrowth.
“Our partnership with Invibio on this project showcases our commitment to pushing the boundaries of medical device innovation,” said Brian Kieser, CEO of Nvision Biomedical Technologies. “This latest FDA clearance builds on a history of successful co-development between Nvision and Invibio, particularly in spine and foot-and-ankle devices. We are thrilled to introduce the 3D printed PEEK Cervical and ALIF lines, available in various footprints and lordotic angles, and all incorporating the same porous design features aimed at promoting bone ingrowth.”
“We’re constantly looking at new ways to equip surgeons with the opportunity to get the best outcomes for their patients. Leveraging this cutting-edge PEEK additive manufacturing platform through Invibio enables us to take a more innovative approach in the design process and address previous limitations,” said Tom Zink, Senior Vice President of Product Development at Nvision Biomedical Technologies.
“These new interbody devices, conceived from the collaboration of Nvision and Invibio, will allow me to further improve the quality of care and surgical outcomes that I can provide to my patients. PEEK-OPTIMA’s modulus of elasticity helps to prevent subsidence. Its radiolucency allows for the confirmation of the fusion process. The benefit of a printed porous structure that mimics native bone allows for bone growth into the device itself – thereby enhancing the construct stability. These combined new implant characteristics of strength, reduced subsidence, boney ingrowth, and radiolucency will provide clinical benefits to all my patients,” said Dr. Steven Lee, a spine and orthopedic surgeon, from the perspective of a clinical end-user.
Nvision and Invibio collaborated in the development of the 3D-printed PEEK Interbody System, with Invibio carrying out development of the PEEK-OPTIMA and Bond3D technology platform, performance testing early in the process, and eventually filing a new master file (MAF) with the FDA to support this and future regulatory submissions.
“The proprietary BOND3D advanced manufacturing process used in this device is available through Invibio to allow device companies to realise their innovative designs. Being able to access this process is a breakthrough for device companies because it allows much greater design freedom that would not otherwise be possible with conventional manufacturing methods”. Devine continued, “The combination of solid and highly intricate porous PEEK-OPTIMA structures within the Nvision system allows for potential bone ingrowth to achieve fixation while maintaining the inherent benefits of PEEK-OPTIMA for imaging and bone-like modulus,” said John Devine, MD of Invibio.
