NuVasive, a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced an expanded US Food and Drug Administration (FDA) 510(k) clearance of the company's TLX Interbody System, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.
The TLX Interbody System is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX Interbody System provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.
Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX Interbody System as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system's size offerings provide multiple options for varying patient size and anatomic considerations.
"With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions," said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. "This clearance highlights our persistant investment in transforming spine outcomes by developing spine's leading procedures, materials, expandables, systems and services."
The TLX Interbody System, coupled with the Company's Integrated Global Alignment (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient's pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine and NuvaMap and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.
"The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures," said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. "The platform also allows me to confirm restoration of my patients' lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients."
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