RAYNHAM, Mass. -- Today, 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.
TELIGEN™ System Tower
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."
The TELIGEN™ System delivers an advanced visualization experience and user-centric procedural control. The digitally enabled TELIGEN VUE™ Camera, located at the distal end of the patient-specific port, eliminates the need for a microscope and can provide an unobstructed view of the surgical site. It offers hands-free visualization during the procedure, along with a multidirectional and expanded field of view. Additionally, the self-cleaning camera includes LED lighting and gives surgeons the ability to manipulate image clarity based on their preference. Moreover, the TELIGEN™ System heads-up display allows for surgeons to maintain ergonomic posture during procedures.12 This may help avoid significant musculoskeletal pain commonly reported by spine surgeons, especially low back and neck pain.13,14
TELIGEN VUE™ Camera
From an economic lens, relative to open TLIF approaches, MIS-TLIF procedures have been demonstrated to reduce overall hospital costs per patient.15 When compared to existing MIS technologies, the TELIGEN™ System aims to deliver efficiencies and cost savings for hospitals. Based on a small cadaveric study (n=6), the TELIGEN™ System reduces fluoroscopy time by 47% (p=0.003) compared to MIS-TLIF procedures performed using a surgical microscope.16 In addition, the TELIGEN™ System provides a reduction in instrument trays and processing costs per surgery for the 10 additional trays not required with the TELIGEN™ System.17,18
"Improving the MIS spinal surgery experience for both patients and surgeons is a critical step to addressing unmet needs in the industry," said Russell Powers****, Worldwide President, Spine, DePuy Synthes. "With our groundbreaking TELIGEN™ Technology Platform, we're providing a better field of view to help improve patient care and increase efficiencies. I'm incredibly proud of this advancement from our DePuy Synthes team and how the VueLIF-T will change MIS spinal procedures."
DePuy Synthes expects the TELIGEN™ System to be available later this year in the U.S. For more information on the VueLIF-T procedure with the TELIGEN™ System and other DePuy Synthes spine specialty products, read more here.
