Orlando, Fla. — Xenix Medical said it has received FDA 510(k) clearance and launched its Lux Expandable Lumbar Interbody Fusion System commercially.
The company said Lux was developed in response to demand for an expandable interbody fusion device that preserves the potential for fusion. Unlike traditional expandable devices, which may use larger expansion mechanisms that occupy space typically reserved for bone graft material, Lux allows significant post-expansion bone graft packing.
The device features Xenix Medical’s NanoACTIV surface technology, which the company said is designed to support postoperative bone growth throughout the device. NanoACTIV is an FDA-designated nanotechnology that includes proprietary macro-, micro- and nanoscale features. Xenix Medical said the technology has been shown in vitro to elicit mesenchymal stem cell differentiation through the osteogenic lineage.
Lux also incorporates the company’s NeoWave matrix architecture, which features uniform edge-to-edge porosity and an internal serpentine wall structure designed to reduce stiffness, point loading and the risk of subsidence.
“Lux is the perfect combination of expandable and fusion technologies,” commented Robert Hirschl, MD, Founder of Xenix Medical and Neurosurgeon in Orlando, Florida. “I have always found the concept of expandable cages to be appealing, since minimally invasive surgery is a big part of my clinical practice. They can be placed through smaller incisions and access windows while minimizing the risk of neural injury or CSF leaks. However, I have avoided using them until now because they have historically suffered from lower fusion rates and greater subsidence than static devices. 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.”
The Lux system offers up to 4.5 mm of post-implantation expansion. It also allows post-expansion bone graft packing through the inserter into a large endplate-to-endplate graft window.
Ryan Phillips, President of Xenix Medical, said the launch expands the company’s line of commercially available products following the launch of its Riva Posterior Fixation System.
“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. I would like to commend our fantastic team for continuing to develop highly differentiated products for a market that is starved for true innovation.”
