4WEB Medical, the first company to receive FDA clearance for an additive manufactured spine implant, has announced that its surgeon customers have implanted over 3, 000 of the company’s 3D-printed orthopedic truss implants.
4WEB Medical Reaches 3, 000 Implant Milestone
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“Crossing the 3, 000 implant milestone is a significant accomplishment for our company, ” said Jessee Hunt, president of 4WEB Medical, in the November 12, 2014 news release. “It is a testament to our surgeons’ positive clinical experience with truss implant technology and the role it may play in achieving better outcomes for their patients.”
4WEB Medical’s 3D-printed technology utilizes engineering principles such as structural mechanics and adjacent material reaction to produce innovative spine implants that may actively participate in stimulating the healing process. “The 4WEB Medical Spine Truss Systems are differentiated from other fusion implants currently on the market because the structural mechanics of the truss implants are designed to distribute loads across the entire endplate and throughout the device, ” said Cameron Carmody, M.D., an orthopedic spine surgeon in Plano, Texas. “This is significant because these implants may reduce stress risers and subsidence-related complications and potentially stimulate a cellular response through a mechanical transduction of strain.”
As noted in the news release, “The truss implant designs have a distinctive open architecture, which allows for up to 75% of the implant to be filled with graft material to maximize bone incorporation. The 4WEB Medical ALIF device has a bi-convex surface that brings the implant and graft material closer to adjacent bone across the entire endplate rather than just around the outside edge.”
Asked where he expects truss sales to be in one year, Hunt told OTW, “4WEB Medical will expand its spine portfolio to include TLIF, PLIF, OLIF, and Lateral truss implant offerings in the first half of 2015 which presents a significant market opportunity. These new releases, along with the rapid market adoption of our foot and ankle wedge solution, should allow the company to more than double our sales by the end of next year.”
Detailing the expansion plans, Hunt added, “With product offerings that now span across multiple market segments including spine and foot ankle, 4WEB Medical’s truss implant technology is truly a broad platform to develop meaningful products across the entire orthopedic arena. The truss designs can be applied to any orthopedic procedure requiring structural support where the patient will benefit from optimal porosity and osseous incorporation. 4WEB Medical’s next area for expansion is the knee market and we are excited to begin the development of our Knee Truss System in early 2015. We have also recently received CE clearance for our products and we plan to accelerate our European commercialization efforts next year.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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