Medical technology company Accelus has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Toro Lateral (Toro-L) Interbody Fusion System.
According to the firm, Toro-L is a biplanar expandable lateral implant with a low insertion profile and direct delivery of bone grafts through the inserter.
The system has a 14mm wide insertion profile that can expand to the implant’s full width of 21mm or 24mm before continuing to extend to the surgeon’s preferred height of up to 16mm.
Accelus said that the implant’s insertion height and fully expanded height are proportional to its lordosis.
During the alpha launch, the implant will be available with a 10-degree lordotic choice and five-degree and 15-degree lordotic options will be available after the full commercial launch.
Because of the additive manufacturing technique, Toro-L has 3D-printed endplates with a roughened surface where the implant meets the bone.
The firm said that the system also includes an inlet retractor which has a feature-rich split-tube design.
Accelus designed the Toro-L system so that the surgeon would never have to open the tube to do the surgery.
The surgeon can fully evacuate the disc space and accommodate the full-width footprint of the extended Toro-L implant using patented disc removal instrumentation along with traditional curettes, rasps, scrapers, kerrisons, and pituitaries.
A rapid and effective post-pack graft distribution method is also included in the system.
Accelus CEO and co-founder Chris Walsh said: “Toro-L was designed to offload the pressure on the innervated posterior psoas muscle without sacrificing footprint.
“Our design team created an implant with a massive footprint that still preserves bony, nerve and ligamentous tissue.
“We strongly believe Toro-L will obviate many of the clinical challenges seen at the L4-L5 levels in the current lateral market.”
In August last year, Accelus announced the launch of ultra-low-profile FlareHawk7 expandable cage implant and innovative instruments to support endoscopic, MIS lumbar fusion procedures.
