Nvision Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, in collaboration with Invibio Biomaterial Solutions, a global leader in high-performance biomaterials, has received FDA clearance for the first 3D-printed porous PEEK Interbody System. The system uses Invibio’s PEEK-OPTIMA™ polymer and the proprietary Bond3D additive manufacturing process. Nvision specializes in creating innovative medical solutions that enhance surgical procedures, while Invibio, part of the Victrex plc group, provides advanced polymer solutions used in over 15 million medical implants.
The 3D printed Interbody System includes devices for Cervical and Anterior Lumbar Interbody Fusion (ALIF). These implants incorporate porous structures designed to promote multi-directional bone ingrowth, which is crucial for enhancing device stability post-surgery. The inherent properties of the polymer allow the implants to match the modulus of elasticity of natural bone, minimizing the risk of implant subsidence—a common challenge in spinal surgery. Additionally, the radiolucent nature of PEEK enables clearer imaging, giving surgeons better visibility to monitor the fusion process without the interference typically associated with metal implants.
Brian Kieser, CEO of Nvision Biomedical Technologies, stated, “Our partnership with Invibio on this project showcases our commitment to pushing the boundaries of medical device innovation. This FDA clearance builds on our history of co-development, particularly in spine and foot-and-ankle devices.” Tom Zink, Senior Vice President of Product Development at Nvision, added, “We’re constantly looking for ways to equip surgeons with the best tools for optimal patient outcomes. The Bond3D process allows us to address limitations in traditional design.”
John Devine, Managing Director at Invibio, emphasized the unique advantages of the approach: “The combination of solid and porous structures in the Nvision system allows for optimal bone ingrowth while maintaining the benefits of PEEK-OPTIMA for imaging and mechanical properties.”
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Clinical Applications and Surgeon Insights
Recent innovations in additive manufacturing are pushing the boundaries of medical applications, particularly in tissue engineering. Researchers at TU Wien have developed a method to 3D print artificial cartilage using bio-ink composed of hydrogel and living cells. This development is particularly significant for addressing joint diseases, offering a promising pathway to creating more durable and functional artificial cartilage. The precise control over the material’s composition allows for mimicking natural tissue more effectively than previous methods.
Meanwhile, a separate team from Carnegie Mellon University introduced 3D ice printing technology, which freezes bio-inks to create scaffolds conducive to tissue growth. This technique offers improved structural integrity and cell viability, allowing researchers to produce more complex tissues. The breakthrough presents a significant leap in creating functional tissue replacements, enhancing the microarchitecture essential for cellular processes.
The combined efforts of companies like Nvision and Invibio, along with cutting-edge academic research, are transforming the medical device landscape, setting new standards for patient care.
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Featured images show a close-up of Nvision’s 3D-printed porous PEEK structure and the Bond3D process used to create medical implants. Photos via Nvision.
