Johnson & Johnson MedTech’s DePuy Synthes this week announced it received FDA 510(k) clearance for its Teligen technology platform for spinal procedures.
Teligen is an integrated technology platform that enables minimally invasive surgical transforaminal lumber interbody fusion (MIS-TLIF) procedures using digital tools for visualization and access. The system has a tower with a camera control system, a VueLIF-T procedure kit with a disposable HD camera, a Teligen clear discectomy device and patient-based disposable ports.
DePuy Synthes’ new system integrates the company’s Unleash bundle of implant solutions that streamline the main stages in MIS-TLIF.
TLIF is a common posterior surgical approach used for treating patients with persistent pain in their lower backs and have spinal instability and fail to respond to noninvasive management. According to the company, TLIF can present clinical challenges like greater soft tissue disruption, increased complication risk, slower recovery and variable long-term outcomes. MIS-TLIF procedures reduce complications from TLIF, but can be associated with limitations, such as lack of consistent visualization, steep learning curves and occupational hazards to surgeons.
“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.”
DePuy Synthes’ Teligen Vue camera is located at the distal end of the patient-specific port and eliminates the need for a microscope and can provide an unobstructed view of the surgical site. It gives a surgeon hands-free visualization during the procedure and a multidirectional and expanded field of view. The self-cleaning camera also includes LED lighting and gives surgeons the ability to manipulate image clarity.
Teligen, in a small cadavers study, reduced fluoroscopy time by 47% compared to MIS-TLIF procedures performed using a surgical microscope. The system also provided a reduction in instrument trays and processing costs per surgery for the 10 additional trays not required with the system, according to the company.
“Improving the MIS spinal surgery experience for both patients and surgeons is a critical step to addressing unmet needs in the industry,” Russell Powers, worldwide president of spine at Depuy Synthes, said in a news release. “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.”
Teligen will be available later this year in the U.S.