Spineology has initiated a full market release of the Elite expandable interbody fusion system. More than 300 cases have been completed using Elite to date.
The Elite expandable interbody fusion system implant is inserted into the lumbar disc space at a contracted minimum height and, once in position, is expanded to restore anatomic disc height, provide anterior column support, and potentially indirectly decompress. The implant is designed to offer surgeons the ability to control device expansion and lock the device at any position in the expansion range. Elite is constructed of titanium alloy and has a large graft window to enable bone through-growth, maximising fusion potential.
“Following the successful completion of the Elite xxpandable interbody fusion system limited release and the receipt earlier this year of the expanded US Food and Drug Administration (FDA) clearance, which included the addition of a narrower 10mm footprint and allograft bone labeling, we have now initiated the full market release of Elite,” said John Booth, CEO of Spineology.
Earlier this year, the FDA cleared the expandable interbody fusion system for a new size and an expanded indication. Included in the clearance is the addition of a narrower, 10mm, version of the device and an indication to utilise the devices with allograft bone.
“The Elite’s robust design, broad size offering and allograft bone labelling—which allows the surgeon to pair [the device] with Incite cortical fibres—have all been received extremely well by our customers,” Booth continues. “We are excited to continue to accelerate the growth of Elite in the expandable cage market.”
Incite cortical fibres offer an osteoconductive and inductive matrix. The bone graft is designed to exhibit excellent handling properties, in-situ expansion, and placement options via a variety of delivery methods.