3D Printed Lateral Spine Truss System Used in First US Surgeries

Metal 3D printing is flying high with recent high-profile use in aerospace systems such as GE’s Advanced Turboprop Engine, which is equipped with one-third of its parts made via additive manufacturing and gearing up for use in the skies within the next two years. While FAA approvals and flight-critical component manufacture have been getting a lot of attention lately, some more down-to-earth applications are having much more personal impact. 4WEB Medical, based in Texas, has been racking up FDA approvals for its innovative 3D printed medical implants — and increasingly putting those approved products to use with patients.

As of 2014, more than 3,000 of their 3D printed spine truss implants were in use. From that milestone, the company has been progressing steadily with additional landmark uses, such as the 2015 implantation of Australia’s first patient-specific 3D printed truss and, in 2016, the first surgical uses of its Curved Posterior Spine Truss System as well as additional business moves with IP protection via a new patent and the FDA approval of its new Lateral Spine Truss System. Adding to its achievements in medical 3D printing, today the company has announced the first surgeries in the US done using its Lateral Spine Truss System.

“4WEB’s spine truss implants have proven to be very effective in providing excellent surgical outcomes for my patients. In contrast to older ring-shaped implants with hollow cores, 4WEB’s truss implant web structure spans the entire endplate providing strong initial fixation and minimizing subsidence,” said Frank Cammisa, MD, Hospital for Special Surgery, New York, NY.

The Lateral Spine Truss System, which received 510(K) FDA clearance almost exactly one year ago, is a lateral interbody fusion device designed to improve the implant experience for patient and surgeon. According to 4WEB Medical, “several notable hospitals in the United States” have successfully performed recent operations using these devices.

“A recent study comparing 4WEB’s lateral truss implant to a ring implant design demonstrated that the truss design had superior resistance to subsidence. In fact, the 40mm length truss implant displayed 61% greater resistance to subsidence than the 60mm length ring implant. These results are indicative of the optimized load distribution inherent to 4WEB’s truss implant technology that maximizes endplate contact while providing an open architecture for bone formation and fusion,” said John Peloza, MD, Center for Spine Care, Dallas, Texas.

The study he references, “Evaluation and Comparison of Subsidence Properties of 4WEB Lateral Device versus an Annular Lateral Device,” was authored by Ali Kiapour, who has previously worked on studies evaluating and comparing 3D printed implants from 4WEB Medical to traditionally manufactured devices as well as others created via additive manufacturing methods.

Now in use in the US, the Lateral Spine Truss System is the latest unique implant from 4WEB Medical to offer benefits to patients via a carefully crafted architecture made possible thanks to additive manufacturing. According to 4WEB Medical:

“The Lateral Spine Truss System is designed with a unique bi-convex dome that distributes load across a larger surface area and has three times more textured surface topography when compared to other competitive spine implants. The key differentiator for the product, though, is its proprietary truss design and the performance it lends to driving successful spine fusion results.”