FDA OKs Xenix Medical’s Lux Expandable Lumbar Interbody Fusion System

Xenix Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Lux expandable lumbar interbody fusion system. The company also initiated full commercial launch.

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 boasts the company’s NanoACTIV surface technology to support post-op bone growth throughout the device.

NanoACTIV is an FDA-designated nanotechnology that comprises proprietary macro-, micro-, and nanoscale features that have been demonstrated in vitro to elicit mesenchymal stem cell differentiation through the osteogenic lineage. The device also incorporates Xenix’s NeoWave matrix architecture, which features uniform edge-to-edge porosity and an internal serpentine wall structure that reduces stiffness, point loading, and as a result, subsidence risk.

With up to 4.5 mm of precise post-implantation expansion, the company said, substantial post-expansion bone graft packing is delivered though the inserter into a large endplate-to-endplate graft window.

Last week, the company won an FDA nod for the Riva Posterior Fixation System and subsequently launched the product to market.

Comments from Xenix Medical

Robert Hirschl, MD, founder of Xenix Medical and Neurosurgeon in Orlando, Fla.: “Lux is the perfect combination of expandable and fusion technologies. 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.”

Ryan Phillips, president, Xenix Medical: “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.”