The FDA recently cleared a significantly interesting new set of MIS-TLIF spine surgery tools. The system, brand named TELIGEN™, comes from DePuy Synthes, the Orthopaedics Company of Johnson & Johnson. To understand what makes this so interesting, here are a handful of its points of differentiation and, we think, clinical relevance for spine surgeons.
TELIGEN received clearance for commercialization in the United States this past October (2022), just under a year from filing on December 20, 2021. It’s indication for use is to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine. Arthroscopic Trocar
OTW had the opportunity to speak with Russell Powers, Worldwide President, Spine at DePuy Synthes, about TELIGEN. You know this is an important launch when DePuy rolls out the big guns.
TELIGEN is an interesting new system. We began this interview by asking Powers to list the ways in which TELIGEN is different from the current MIS-TLIF spine systems.
DePuy (Russell Powers): Thanks for that question, Robin. We really believe that TELIGEN and the TELIGEN system, along with the VueLIF-T procedure, has the potential to change minimally invasive spine surgery as we know it today.”
“When you think about the different approaches to treating low back pain and degenerative disc disease, the TLIF procedure, the transforaminal lumbar interbody fusion, is the most common posterior surgical approach, and it has a very favorable fusion rate.”
“Over the last 10 plus years performing the TLIF minimally invasively, the MIS approach has reduced overall complications associated with the traditional open procedure. But even with the MIS-TLIF, there remain limitations. Lack of consistent visualization. Occupational hazards for the surgeon which develop as the surgeon stands over the patient for an extended length of time, looking down a very small aperture, usually around 22 to 26 millimeters in diameter.”
“What’s different about TELIGEN is that it provides for an advanced visualization experience and user centric procedural control, which starts with the TELIGEN Vue camera. The camera is actually located at a distal end of a patient specific port. The camera slides down the port, and now the surgeon has eyes inside the surgical site.”
“This eliminates the need for a microscope. And it delivers an unobstructed view of the surgical site.”
OTW: How does that in-the-port camera communicate to the tower and that high-definition monitor? Infrared system or Bluetooth system?
DePuy (Russell Powers): “Cable. The camera is connected to the tower through a cable. And we have lights at the end of the camera. The camera has 22.5 degrees of directional view, and it transmits the image from inside the portal onto a 4K HD screen.”
“This display gives the surgeon direct visualization and line of sight to the screen. It helps the surgeon maintain an ergonomic posture. Remember, the surgeon must stand through the two, four or six hours of the procedure looking down a small aperture. Not only does the surgeon have direct line of sight to the screen and to the image, but the entire surgical team now has a direct line of sight as well.”
OTW: That is terrifically cool.
DePuy (Russell Powers): “We think it’s a game changer. We spent a lot of engineering hours on the camera itself. The camera, incidentally, also works in a dry environment. When you think about traditional endoscopic surgery or arthroscopy surgery like in sports medicine, it requires fluid management. It requires a wet environment to have a clear picture of what's happening at the end of the scope.”
“This particular camera works in a dry environment and there is a very cool cleaning component to it. This was one of the biggest engineering challenges that we had to overcome. It's just like cleaning a windshield. You press a foot pedal; it flushes the tip of the camera with a little saline and in literally less than 10 seconds, clarifies the image.”
OTW: Wow. A miniature camera that sits at the distal end of the surgical port and has a windshield washer. Who were your KOL’s working with you on the TELIGEN system?
DePuy (Russell Powers): Dr. Michael Wang, Professor of Neurological Surgery and Chief of Service, Medical Director, Minimally Invasive Spine at the University of Miami Miller School of Medicine was closely involved with this project. Along with Dr. Wang, Dr. Rick Fessler, and Dr. Bill Taylor were among the six talented surgeons contributing on this important project.
OTW: Dr. Wang has also been a key part of our Skills Based Master Class programs for MIS lateral and other spine surgery skills based online classes. He’s a great instructor. An international leader in MIS spine.
DePuy (Russell Powers): “Finally, we really think that this is going to deliver efficiencies and cost savings to the hospital. We did a small cadaver study with the TELIGEN system. We found that in that study, with TELIGEN, the use of fluoroscopy was reduced by 47% compared to the traditional TLIF procedure using a microscope.”
“It will also reduce the number of instrument trays, processing time, and cost per surgery. For a traditional MIS-TLIF, a surgeon will need up to an additional 10 trays. We designed in multiple advantages to the surgeon, but also efficiencies and cost savings to the hospital with TELIGEN.
OTW: Russell, thank you for taking the time to explain this very interesting new approach to MIS TLIF. IF you don’t mind, we’d like to check back with you after a few months and see how the reaction has been among spine surgeons.
You can find more information about TELIGEN here.
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