Maximum Access Surgery® (MAS) Transforaminal Lumbar Interbody Fusion (TLIF) is a surgical procedure that was developed to provide spinal stability and help reduce pain in the lower back and lower extremities by using a less disruptive surgical procedure. We’re featuring MAS TLIF and TLX™ innovators, Chris and David, to give you an inside look into what it’s like helping drive innovation at NuVasive. Read their interview below:
What sparked the need for MAS TLIF and TLX?
- Chris, Engineering: Traditionally in order to restore disc height through a TLIF approach surgeons impact or insert and rotate large devices past the exiting and traversing nerve roots of Kambin’s triangle. The issue with this approach is that the window in which the surgeon has to work can be really small, which adds risk to the procedure. Providing an expandable interbody device removes some of that risk as it allows the user to implant a smaller device past the nerve roots and into the disc space where the user can expand the implant to fit the patient’s anatomy.
- David, Marketing: We saw the market shift from not only PEEK to titanium implants but also to expandable cages. Implants that could go in small and be expanded to restore disc height and create lordosis were gaining in popularity. We saw an opportunity to address an unmet clinical need with an obliquely lordotic expandable interbody that could provide anterior column stability and restoration of sagittal alignment through a posterior approach.
What were the resources needed to start this project?
- Chris: As with any project, we needed to start with the requirements where we rely heavily on our marketing and surgeon design teams for. Once a rough draft of the requirements were in place the majority of time at the beginning of the project was spent brainstorming, designing and evaluating potential concepts within the development group. From there prototypes of viable concepts would have been manufactured using the machine shop or 3D technology where we have the capability to quickly print and iterate designs in plastic or steel.
- David: We needed an all-star, cross functional team to work together to create a very complex product. A huge part of project was having an engineer that could design and create an implant that hadn’t existed before. There was no predicate implant to go off of so we were dealing with a blank slate. We had great minds collaborating to determine design requirements but nothing would have been a reality without Chris designing and creating a truly game changing interbody system.
Usually the first idea might not be the greatest idea. Was the original idea for TLX what it is today? If it has changed, what necessitated the change?
- Chris: All of the projects that we work on evolve overtime and this was no different with TLX. The general requirements are usually fixed and tend not to change, but the designs do. For TLX our high level goal was to develop an expandable oblique TLIF cage that expanded to increase in lordosis, could be graft packed through the inserter and was an easy to use system with minimal steps. We were able meet this goal throughout the project, but along the way through either meetings with our design surgeons, internal labs, team meetings or the alpha evaluation we identified areas where the system could be improved and did so.
- David: Designs always change in some way during projects through the different phases of development and for various reasons. Cadaver labs and clinical use in the alpha period prompted minor updates to the implant and instrumentation to create the premier system that is launched in the market today.
What was your favorite part about the design and marketing process for TLX?
- Chris: My favorite part of the design process is being challenged up front to come up with solutions for a design or to solve a problem. It’s extremely rewarding when you finally lock into a design and then see that taken into launch and used clinically.
- David: My favorite part was knowing we were going to be able to offer surgeons leap frog technology with a truly unique implant. Knowing how much demand there was for an expandable TLIF cage from the market and being able to provide our sales force with an interbody that we knew would be truly disruptive as a great clinical solution for surgeons and their patients was very gratifying.
What skills did you have to acquire to be able to create TLX?
- Chris: Coming from an ALIF project, it was extremely important that I learned the TLIF procedure and understood the challenges that surgeons faced.
- David: Working on only static cages prior to TLX it was critical to understand the more complex design of an expandable cage and instrumentation, and the best way to position TLX against competitive expandable cages.
Would you like to share anything else about MAS TLIF and the making of TLX?
- Chris: The TLX project will be wrapping up later this year when we commercially launch the TLX 20° system. None of this would have been possible without the help of an entire group of talented and dedicated individuals from across the company that came together as a team to launch this game changing system. All of the following individuals played a role in the success of TLX and in no specific order I would like to thank: David, Bailey, Tim, Mike, Kiel, Andrew G., Andrew M., Gabriel, Sean, Matt, Jennifer, Nick, Michael, Jasmine, Chase, Ruben, Mike, Leo, Cliff, Noe-Michel, Juan, Alvin, Glenn, Ryan, Eric, and our surgeon design team Dr. Hunter, Dr. Theofilos and Dr. Shaffrey.
- David: We are in an exciting growth period with our TLIF procedure with MAS TLIF 2 and TLX providing surgeons with amazing tools to treat their patients. We have an outstanding cross functional team working on these products which all require a true team effort to execute on successfully. I’d like to echo thanks to the team above including Chris Stein who is the engineer who brings these ideas to life.
View our other Innovator Interviews: XLIF® Crestline™, Modulus® XLIF, and Lateral ALIF™.
If you’re interested in becoming part of the innovation here at NUVA, search our open roles here.