The TLX interbody system developed by NuVasive, Inc. (NASDAQ:NUVA) has been granted clearance by the Food and Drug Administration. The new clearances allows for broader indications as well as the introduction of an expandable cage of 20 degrees. Inserted via TLIF approach which is minimally invasive, these implants are able to be placed seamlessly. There is also a proprietary inserter which enables high surgical efficiency.
“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 Nuvasive’s technology, strategy, and corporate development executive vice president, Matt Link.
TLX Interbodies
Before the clearances were expanded, TLX interbodies were only indicated to be used with allograft and only had 15 degree options. In its last reported quarter there was a 3% growth recorded in the spinal hardware business in the United States.
Nuvasive also recently acquired Vertera Spine, a company which operates in the spine hardware space. Additionally Nuvasive unveiled the LessRay software system which is used to address the issue of radiation overexposure in the operating rooms of hospitals. This is especialy when conducting spine surgery that is minimally invasive.
Per a report prepared by GlobalData, the worldwide market in the spinal fusion space is slated to grow to reach a figure of $9 billion by the year 2023. This will mean that it will have grown at a compounded annual growth rate of 3.4%.
Expanded clearances
The expanded clearances coincide with Nuvasive unveiling titanium implants known as Modulus XLIF which have been developed using 3D printing. By making use of additive manufacturing technology Nuvasive intends to come up with a porous, organic architecture which mimics the stiffness and porosity of bones in order to reduce stress shielding.
And in comparison with the regular titanium interbody devices, the Modulus XLIF offers an ideal bone in-growth environment. Additionally the optimized architecture of the device allows for improved imaging characteristics vis-à-vis the regular interbody devices.
On Friday shares of NuVasive Inc rose by 0.88% to close the day at $55.05.
