The company that has pioneered Truss Implant Technology™ for interbody fusion devices, Frisco, Texas-based 4WEB Medical (4WEB, Inc.), has announced the launch of a stand-alone anterior lumbar interbody fusion (ALIF) device.
Novel Stand-Alone Anterior Lumbar Device Launched
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The Stand-Alone Anterior Spine Truss System™ (ASTS-SA) device uses the company’s truss technology that allows for bone through growth and load distribution across the device to stimulate bone growth. The company launched the cervical stand-alone cage late last year.
The first fusion procedure was performed by James Lynch, M.D., who is a neurosurgeon and CEO of Spine Nevada in Reno, Nevada. “The addition of integrated screws to the implant allows for an ALIF procedure that eliminates the need for supplemental fixation or plating. This, coupled with all of the advantages provided by 4WEB’s proprietary truss technology, results in not only a cost savings, but also a quicker and more minimally invasive procedure that improves patient safety, and enhances clinical outcomes,” explained Lynch.
The ASTS-SA includes 3 titanium alloy screws that stabilize the vertebral endplates to the zero-profile device. A locking mechanism is also included to prevent screw backout. A range of footprints, heights, and lordotic angles are available. The truss system helps apply Wolff’s law to stimulate bone growth across the entire surface of the device by distributing the load.
Company Vice President of Marketing Tasha White explained the expected impact the launch will have on the company, “The launch of the stand-alone anterior interbody implant is a significant milestone for 4WEB and is the latest example of the company’s continued commitment to invest in product development, clinical research, and procedural based solutions. We are excited to provide this best in class procedural solution and anticipate that this product will drive considerable revenue growth for the company.”
The device was cleared by the U.S. FDA in May 2020, and is indicated for fusion of up to 2 contiguous levels between L2-S1 without supplemental fixation, except in the case of the hyperlordotic option (>20o), in which case posterior fixation is required. The company also offers osteotomy systems for foot and ankle surgery.
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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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