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FDA approves expanded indication for NuVasive’s TLX interbody system

MDBR Staff Writer Published 17 October 2017

The US Food and Drug Administration (FDA) has approved an expanded indication for NuVasive’s TLX interbody system to use in spinal fusion surgery.

The clearance is said to introduce an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and additional levels of the spine.

NuVasive’s TLX interbody system is an advanced solution, which can be inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach.

The company has developed a minimally invasive approach for the TLIF procedure called Maximum Access Surgery (MAS) TLIF.

Developed 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 and bulleted design.

Designed to induce lordosis in an anatomical way, the TLX interbody system offers restoration of sagittal alignment with customizable degrees of lordosis.

TLX interbodies were available in 15 degree lordotic options before the expanded 510(k) clearance, which are only indicated for use with allograft.

The currenr clearance allows to use the system with 20 degree expandable interbody, in addition to allogeneic bone graft comprised of cancellous or corticocancellous bone graft to facilitate fusion.

NuVasive’s TLX interbody system, along with Integrated Global Alignment (iGA) software suite enables surgeons to calculate, correct and confirm a patient’s pathology.

 NuVasive strategy, technology and corporate development executive vice president Matt Link said: “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.

“This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.