Vy Spine and Nvision Biomedical Technologies have both recently announced FDA clearance for their respective 3D-printed spinal implant systems. These clearances mark a significant advancement in the use of additive manufacturing for medical devices, offering potential benefits in terms of osseointegration, biocompatibility, and imaging.
Vy Spine's LumiVy OsteoVy PEKK Lumbar IBF
Vy Spine's LumiVy OsteoVy PEKK Lumbar IBF device received FDA clearance for intervertebral body fusion in the lumbar spine (L2 to S1). The device is indicated for treating degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. The implant combines the osseointegration properties of 3D-printed OXPEKK material with Vy Spine's OsteoVy lattice structure.
The LumiVy OsteoVy PEKK Lumbar IBF is available in various footprints and heights (6mm to 21mm) to accommodate different lumbar interbody approaches, including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. It also comes in a range of lordosis and hyperlordosis options. The system includes IBF-S implants with self-drilling screws for direct bone anchoring.
OXPEKK has demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, increased bony apposition over time, and higher push-out strength compared to standard PEEK. Additionally, OXPEKK is bacterostatic and suitable for patients with metal hypersensitivity. Vy Spine's OsteoVy lattice structure promotes bony integration and wicking, enhancing the interbody implant's benefits.
"The LumiVy OsteoVy PEKK Lumbar IBF clearance is another product in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs," said Bret Berry, President of Product Development for Vy Spine. Scott DeFelice, CEO of Oxford Performance Materials, added, "We are confident that the combination of OPM’s novel 3D printed PEKK technology and Vy Spine’s unique designs & experience within the spine marketplace will drive substantial adoption of this best-in-class solution."
Nvision's 3D-Printed PEEK Interbody System
Nvision Biomedical Technologies also announced FDA clearance for its 3D-printed PEEK Interbody System, which utilizes PEEK-OPTIMA polymers from Invibio Biomaterial Solutions and Bond3D additive manufacturing technology. The system includes Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices, both featuring porous structures designed to promote multi-directional bone ingrowth and improve device fixation.
The use of PEEK-OPTIMA offers mechanical properties closer to bone and superior imaging capabilities compared to titanium implants, allowing surgeons to monitor fusion progression more accurately. The system combines PEEK-OPTIMA with design freedom enabled by Bond3D AM technology, printing solid and porous areas for bone ingrowth.
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. 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."
John Devine, MD of Invibio, noted, "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."
