Medical technologies provider Spineology has received expanded clearance from the US Food and Drug Administration (FDA) for its Elite expandable interbody fusion system.
The Elite expandable interbody fusion system is an implant that can be inserted into the disc space at a contracted minimum height.
The device is then expanded to restore anatomic disc height, support the anterior column and potentially allow indirect decompression.
The FDA clearance includes a narrower, 10mm version of the device and an indication to utilise the devices with allograft bone such as Incite Cortical Fibers.
Incite Cortical Fibers are osteoconductive fiber-based bone allografts that are designed to maintain their osteoinductive potential.
Spineology chief executive officer John Booth said: “The broader size offering and the allograft bone indication allow the surgeon to pair Elite with Incite Cortical Fibers.
“Incite’s excellent handling properties and ability to expand in-situ with the Elite Implant are added benefits not found in competitive systems.”
While the expanded indication of the minimally invasive Elite implant to add a 10mm wide footprint decreases neural retraction requirements, its combination with Incite enables graft apposition.
The Incite grafts are freeze-dried to allow their expansion when hydrated in-situ, preventing graft off-loading after implant expansion.
The system allows surgeon to control device expansion and lock it at any position in the expansion range, while its titanium alloy and large graft window facilitate bone through-growth to maximise the fusion potential.
With commitment to increase procedural efficiency, minimise surgical morbidity and enhance patient recovery, Spineology focuses on surgical techniques that conserve spinal bone, ligament and muscle tissue.
Image: Elite Expandable Interbody Fusion System with fibers. Photo: courtesy of Spineology.