Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the U.S. Food and Drug Administration (FDA) has cleared the first 3D-printed PEEK-OPTIMA interbody system for spinal fusion. This system, developed in collaboration between San Antonio-based medical device company Nvision and UK-based Invibio, uses the Bond3D additive manufacturing process to produce implants with solid and porous structures designed to promote bone ingrowth.
Brian Kieser, CEO of Nvision Biomedical Technologies, commented “Our partnership with Invibio on this project showcases our commitment to pushing the boundaries of medical device innovation”. Kieser continued “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.”
The new PEEK interbody system includes implants for cervical and lumbar fusion and combines the mechanical advantages of PEEK-OPTIMA with the flexibility of 3D printing. PEEK-OPTIMA, a polymer used in over 15 million implants worldwide, offers mechanical properties closer to those of bone, as well as better imaging capability compared to titanium implants. This allows surgeons to monitor the progress of bone fusion more accurately. The porous structures in the implant are specifically designed to support bone growth in multiple directions, allowing for a more stable fixation of the implant.
Tom Zink, Senior Vice President of Product Development at Nvision Biomedical Technologies, added “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.”
Dr. Steven Lee, MD a spine and orthopedic surgeon gave a clinical end-user perspective, stating – “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.”
John Devine, Invibio Managing Director said “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.”
With the FDA clearance, Nvision and Invibio are committed to the further development of 3D-printed PEEK technology and plan to use it in additional medical applications.
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