No longer are 3D printed medical implants a thing of science fiction, as our readers know. Now, two companies, Nvision Biomedical Technologies and Invibio Biomaterial Solutions, have co-developed the first 3D printed PEEK Interbody System, consisting of devices for spinal infusions. Specifically, they created Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices using PEEK-OPTIMA™. Last week, they announced that the U.S. Food and Drug Administration (FDA) granted clearance for their interbody system, so it will now be available for clinical use.
PEEK, or polyether ether ketone, is a semi-crystalline thermoplastic often used for medical applications because it is sterilizable, biocompatible, and heat, wear, and chemical resistant. PEEK has properties similar to bone, meaning, if implanted, it can promote the reconstruction of tissues around the implant, accelerating osseointegration. PEEK-OPTIMA has already been used in over 15 million implants, and its superior imaging capability also allows surgeons to accurately monitor fusion progression.
This close-up of the Nvision Interbody System shows its porous PEEK-OPTIMA structure (photo credits: Invibio)
Nvision and Invibio’s ALIF spine devices each incorporate porous and solid structures. John Devine, MD of Invibio, defined their purpose, explaining that “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.”
Creating a 3D Printed Spinal Device
The team employed BOND3D’s technology for the job, and BOND3D’s parts have isotropic strength in all directions and are 100 percent voidless. With additive manufacturing, Nvision and Invibio were allowed unparalleled design freedom. John Devine, MD of Invibio, explained the advantages of 3D printing for this project.
He elaborated, “The proprietary BOND3D advanced manufacturing process used in this device is available through Invibio to allow device companies to realize 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”.
Dr. Steven Lee, MD, a spine and orthopedic surgeon, offered insight into how the Nvision and Invibio devices will impact his practice. “These new interbody devices,” Dr. Lee said, “will allow me to further improve the quality of care and surgical outcomes that I can provide to my patients.”
He further explained that “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.”
Nvision Biomedical Technologies is a medical device and implant manufacturer based in San Antonio, Texas USA and Invibio Biomaterial Solutions, based in Lancashire, UK, provides high-performance biomaterial solutions to medical device manufacturers. To read more about their partnership and the FDA approval of their ALIF devices, read Invibio’s press release here.
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