USA — The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Johnson & Johnson’s Teligen System for use in certain spinal surgery procedures.

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.

Teligen is a technology platform developed by J&J’s Orthopedics unit DePuy Synthes that enables minimally invasive surgical transforaminal lumbar interbody fusion (MIS-TLIF) procedures via digital visualization and access tools.

The system is expected to be available in the United States later this year, according to a press release issued by the company.

The Teligen System is said to be an integrated technology platform that uses digital tools for visualization and access.

It features a tower that includes a camera control system, a VueLIF-T procedure kit with a disposable HD camera, a Teligen Clear Discectomy Device, and patient-based disposable ports.

According to Johnson & Johnson MedTech, the system integrates with the UNLEASH bundle of implant solutions, which is designed to simplify the key phases in MIS-TLIF.

 It also offers an advanced visualization experience and user-centric procedural control.

The digitally equipped Teligen VUE Camera of the platform removes the requirement for a microscope and can offer an unhindered visualization of the surgical site. It enables multidirectional, expanded, and hands-free view during the procedure.

According to the firm, the heads-up display of the Teligen System enables surgeons to keep a comfortable posture while operating.

Surgeons could adjust the image clarity as per their preference using the self-cleaning camera, which also has LED lighting.

Additionally, the system merges with the UNLEASH bundle of implant solutions, which is created to simplify the key MIS-TLIF stages.

As against current MIS technologies, the Teligen System could be efficient and cost-effective for hospitals.

Based on small cadaver research, the Teligen System was found to speed up MIS-TLIF procedures when compared to those done under a surgical microscope by 47%, said Johnson & Johnson MedTech.

DePuy Synthes Spine worldwide president Russell Powers said: “Improving the MIS spinal surgery experience for both patients and surgeons is a critical step to addressing unmet needs in the industry.

With our groundbreaking Teligen Technology Platform, we’re providing a better field of view to help improve patient care and increase efficiencies.”

In November last year, the company introduced the UNIUM System for small bone, sports medicine, spine, and thorax procedures.

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