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NuVasive's TLX Interbody System Gets Expanded FDA Approval

NuVasive, Inc. NUVA received an expanded 510(k) clearance from the FDA for its TLX interbody system. The TLX interbody system is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. TLX implants can be placed easily into the disc space due to their low profile, bulleted design. TLX is designed for a minimally-invasive spine surgery approach.

TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft before the receipt of the approval. According to the company, new clearance includes an expandable 20 degree interbody and broader indications for use, including use with allogeneic bone graft and in additional levels of the spine. The TLX system's size offers many options for varying patient size and anatomic considerations.

The TLX interbody system, combined with the Integrated Global Alignment (iGA) suite of the company’s software, has the ability to improve overall TLIF procedures.

Notably, NuVasive is currently leaving no stone unturned to cash in on the rapidly-evolving spine market. During the last reported second quarter of 2017, the company’s core U.S. spinal hardware business maintained the bullish trend with 3% growth. The upside was driven by strong adoption of ReLine posterior fixation system within the company’s iGA platform. The company also witnessed a steady uptake of its recently-launched expandable interbody cages and base TI interfixated within the ALIF procedure.

Meanwhile, the company recently closed the acquisition of Vertera Spine, a start-up company in the spine space. NuVasive also announced the commercial launch of LessRay software technology system. It particularly works to help address overexposure to radiation in hospital operating rooms (O.R.), mostly in the case of minimally invasive spine surgery (MIS).

According to a report by GlobalData, the global market for spinal fusion is expected to rise around $9 billion by 2023, at a CAGR of 3.4%. Considering the substantial potential of the market, we believe the latest development is a strategic one.

The spine market is dominated by many well-established players like Stryker Corporation SYK, Zimmer Biomet Holdings, Inc. ZBH and RTI Surgical RTIX, among others.

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