Just a month after announcing FDA 510(k) clearance of its PROLIFT® Lateral Expandable Spacer System, on July 25, 2019, Illinois-based Life Spine, Inc. announced clearance for additional widths of the system.
Lateral Expandable Spacer Gets Broader FDA Clearance
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The new 8mm-10mm cleared widths, according to the company, will more than double the current footprint options to accommodate a wider range of patients.
Mariusz Knap, the company’s marketing and business development VP, said as with the company’s other expandable devices, the new additions can be post-packed in situ and “feature our proprietary OSSEO-LOC™ surface technology with 400-600 microns of porosity creating an environment for potential bone on-growth.”
Unlike traditional static interbodies, the company says its system was engineered, “to reduce the need for surgical steps, such as sequential trialing, and in turn reduce operating time. Additionally, the new smaller widths are designed to decrease patient trauma through smaller incisions and less retraction.”
Indications for Use
According to the original FDA clearance documents, the system is intended “for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).”
The system is to be used in patients who have had at least six months of non-operative treatment. “Patients with previous nonfusion spinal surgery at involved level(s) may be treated with the device.”
“The device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.”
The system is complemented by the company’s full lateral portfolio which consists of the CENTRIC® Retractor, Lateral Disc Prep, OSTEO-LINE® Graft Delivery Device, Neuromonitoring Instruments, LONGBOW® Expandable Spacer System and the SENTRY® Lateral Plating Systems.
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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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