Xenix Medical today announced FDA 510(k) clearance and full commercial launch for its Lux Expandable Lumbar Interbody Fusion System.
Whereas traditional expandable devices incorporate bulky expansion mechanisms that occupy space typically reserved for bone graft material, Lux allows for significant post-expansion bone graft packing and features the company’s NanoACTIV surface technology to support postoperative bone growth throughout the device. NanoACTIV, an FDA-designated nanotechnology, comprises proprietary macro-, micro-, and nanoscale features that have been shown in vitro to elicit mesenchymal stem cell differentiation through the osteogenic lineage.
The device also incorporates the company’s signature NeoWave matrix architecture, featuring uniform edge-to-edge porosity and an internal serpentine wall structure that reduces stiffness, point loading, and, thus, 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.”
Key Features of the Lux Expandable Interbody Fusion System:
- Up to 4.5mm of precise post-implantation expansion
- Substantial post-expansion bone graft packing delivered through the inserter into a large endplate-to-endplate graft window
- NanoACTIV surface technology
- Subsidence mitigation through the company’s proprietary NeoWave matrix architecture
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. I would like to commend our fantastic team for continuing to develop highly differentiated products for a market that is starved for true innovation.”
