Xenix Medical has obtained US Food and Drug Administration (FDA) clearance for its Lux expandable lumber interbody fusion system and announced the product’s launch on the US market.
Lux is comprised of Xenix’s NeoWave matrix spacer implants and NanoActiv technology. The former is designed to mimic the structure of natural bone to encourage bone growth and reduce the implant’s risk of sinking into the vertebrae, while the latter’s surfacing technology is intended to ensure that implants remain in placed once fitted.
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Xenix said it developed Lux due to strong market demand for an expandable interbody fusion device that did not compromise the potential for fusion. With this in mind, Lux is also designed to provide greater flexibility to orthopaedic surgeons when undertaking posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) spine surgeries, allowing for up to 4.5 millimetres of post-implantation expansion once placed.
PLIF and TLIF are common types of lower back surgery wherein unstable spinal vertebrae are fused together, either to relieve nerve compression or treat conditions such as degenerative disc disease or spinal stenosis.
GlobalData analysis reveals that the global spinal fusion market is growing at a compound annual growth rate (CAGR) of 1.4% and is projected to reach a valuation of around $17.5bn in 2035.
According to Xenix Medical founder, Robert Hirschl, expandable cages have historically suffered from “lower fusion rates and greater subsidence” (implants sinking into the vertebrae) as compared with static devices.
He commented: “Lux was developed to address these shortcomings with its large open graft window, NanoActiv surface technology, and NeoWave endplates and side walls. The early results have been extremely encouraging as expected.”
Xenix’s FDA clearance for Lux comes just a week after the agency cleared the Florida-based company’s Riva posterior fixation system, a toolkit of pedicle screws for stabilising spinal segments following the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, or sacral spine.
Ryan Phillips, president of Xenix Medical, commented: “We are excited to add Lux to our rapidly expanding line of commercially available products, especially on the heels of last week’s full commercial launch of our Riva posterior fixation system.”
