Novel 3D Printed Lateral Interbody Device Launched

Orthofix Global Spine has announced the full U.S. commercial launch of the WaveForm^® L Lateral Lumbar Interbody System. The 3D-printed WaveForm L, meant for lateral lumbar interbody fusion (LLIF), features a porous structure focused on strength and stability to provide a robust fusion environment.

“Designed to treat the spine safely and reproducibly through indirect decompression and sagittal alignment restoration, the WaveForm L features a large core aperture for the placement of bone graft material to optimize bony fusion throughout the interbody,” said Donald Blaskiewicz, M.D., director of Spinal Deformity at St. Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in San Diego, California. “The WaveForm L also has improved imaging characteristics to aid in radiographic visualization during intraoperative and postoperative imaging. These combined features make it one of the best 3D-printed interbodies available.”

WaveForm interbodies are uniquely created with a primary focus on structure, surface and stability, says the company. “Constructed from a repeating wave-like structure, WaveForm L is designed to efficiently distribute compressive loads and provide high porosity for optimized stiffness without compromising strength.^1,2 At 80% body porosity, WaveForm L provides enhanced imaging characteristics and increased graft packability, while the optimized 65% endplate porosity of the wave-like structure provides for boney ingrowth and early mechanical stability.” ^3,4,5

When asked how the size of the aperture differs from existing systems, Orthofix Global Spine President Kevin Kenny told OTW, “WaveForm L features an innovative graft aperture that mates directly with our best-in-class biologics. When coupled with OsteoStrand^® Plus, an osteoinductive environment is created within the WaveForm interbody, where the graft can flow from the inside out, forming a connection endplate to endplate, and ultimately be contained within the WaveForm structure.”

Regarding how the imaging characteristics been improved, he added, “Waveform L’s 80% body porosity and sheet-based gyroid design requires less material to achieve the desired strength. In turn, less titanium aims for improved imaging and imaging contrast.”

References

1. Data on file, TM-0043-22
2. Kelly, Cambre N., et al. “Design and structure–function characterization of 3D printed synthetic porous biomaterials for tissue engineering.” Advanced healthcare materials 7.7 (2018): 1701095.
3. Data on file, TM-0071-23
4. Data on file, D0006845
5. Kelly, C. N., Wang, T., Crowley, J., Wills, D., Pelletier, M. H., Westrick, E. R., Adams, S. B., Gall, K., & Walsh, W. R. (2021). High-strength, porous additively manufactured implants with optimized mechanical osseointegration. Biomaterials, 279, 121206.