Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TELIGEN™ System, an integrated technology platform that enables minimally invasive surgical transforaminal lumbar interbody fusion (MIS-TLIF) procedures through digital tools for visualization and access. The TELIGEN™ System is comprised of a tower that delivers a suite of technologies, including: a camera control system, a VueLIF-T™ Procedure Kit with a disposable HD camera, a TELIGEN™ Clear Discectomy Device and patient-based disposable ports. The TELIGEN™ System integrates with the UNLEASH™ bundle of implant solutions, which is designed to streamline the main stages in MIS-TLIF.
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Low back pain is the leading cause of years lived with disability globally, with prevalence estimated to be about 7.5% of the population worldwide, or around 577 million people.1 For patients with degenerative disease, persistent pain, and spinal instability who fail to respond to noninvasive management, surgical interbody fusion may be the best option. Transforaminal lumbar interbody fusion (TLIF) is a common posterior surgical approach with favorable fusion rates.2 Open TLIF, however, can present clinical challenges, including greater soft tissue disruption2, increased complication risk3-6, slower recovery7,8, and variable long-term outcomes, such as greater back pain and disability.8 MIS-TLIF techniques have evolved to reduce complications seen with open TLIF2; however, they may be associated with certain limitations, such as lack of consistent visualization9, steep learning curve9, and occupational hazards to the surgeon.10,11
“The DePuy Synthes TELIGEN™ System with VueLIF-T procedure has the potential to change MIS spinal surgery as we know it,” said Dr. Michael Wang***, Professor of Neurosurgery and Rehab Medicine at the University of Miami Medical Center. “With the TELIGEN™ System, we will have a larger and clearer field of view – something we’ve never had before. This expanded visibility will be invaluable to improving surgical performance and ultimately delivering better patient outcomes.”