Transforaminal lumbar interbody fusion (TLIF), a common lumbar fusion procedure, doesn't normally present a particularly long learning curve for most spine surgeons. A minimally invasive TLIF involving a muscle-sparing, muscle-splitting incision, can result in less pain and less blood loss. Patients experience a quicker recovery, often returning home the day after the procedure. However, this MIS approach has its’ own reproducibility and learning curve:
- Discectomy can make or break a fusion procedure, but surgeons often face difficulty using standard discectomy tools in an MIS TLIF approach.
- The small TLIF entry point requires nerve retraction in order to pass instruments by the nerve root and dura when performing a discectomy.
- Limited exposure and visualization of the disc space create challenges for surgeons through the small MIS TLIF working corridor.
Benvenue Medical has developed GuardRail, a novel minimally-invasive discectomy system, which assists surgeons in achieving a rapid, complete discectomy while offering a protected working corridor that insulates the nerve roots and dura from multiple passes of instruments throughout a TLIF procedure.
"Especially with new surgeons, where they don't have the experience of tactile feedback, having something like the GuardRail, which protects surrounding nerve roots and dura from injury, that's an extra layer of protection for the patient," says Adam Lewis, MD, of Jackson (Miss.) Neurosurgery.
GuardRail consists of a nitinol rail that establishes a protective circular barrier within the disc space that allows a proprietary set of tools to cut, disrupt, scrape and extract disc material and prepare the vertebral endplates for fusion.
"The GuardRail technology is an innovation to disc and endplate preparation for lumbar fusion," says Dr. Lewis. "It's easy to use and the learning curve is not steep."
Sandeep Kunwar, MD, of Fremont, Calif.-based Bell Neuroscience Institute of Silicon Valley, agrees: "The Guardrail is pushing the limits to say how we do a TLIF discectomy."
Unlike other discectomy tools, the GuardRail system features a protective dual lumen cannula, which docks in the disc space and deploys the cannulated rail. This novel cannula and rail establishes the safe corridor and perimeter for passing instruments into the disc space. Spine surgeons can pass the discectomy instruments multiple times through the corridor, thereby protecting the DRG, nerve roots and dura while achieving a reproducible discectomy.
"One of the challenges, by working through one side, is that it's often difficult to have instruments that reach across into the contralateral disc space, so the GuardRail provides the technology to do that in a safe way," says Dr. Lewis. Dr. Kunwar adds, "the technology speeds up the operation as makes it easier to pass instruments."
The key features of the GuardRail system include:
- Reproducible disruption and extraction of the disc material, while removing the cartilaginous endplates and preparing a bony fusion bed.
- Limited nerve retraction.
- Protection of nerves and blood vessels throughout discectomy.
- Significant reduction of instrument passes by the nerve root versus multiple passes.
- Shortened operating time.
- Adaptable to minimally invasive and traditional techniques.
- Deployable in most collapsed disc spaces as low as 5 mm in height.
- Removes a 26 mm diameter area of disc to allow for placement of a large amount of graft.
- GuardRail is a fully-integrated discectomy system that is complimentary to the Luna 3D Expandable Interbody Implant.
"[The GuardRail] provides a consistent sweep of all the disc material, so there's more of a window to put a large implant and place graft material," Dr. Lewis says. Specifically, the GuardRail technology is compatible with Benvenue's Luna 3D implant.
GuardRail is in early clinical validation and will be commercialized in early 2017. Please contact Benvenue Medical (benvenuemedical.com) for more information.
If you have any questions or would like to speak with a corporate representative,please contact our Customer Service department at (408) 454-9300 or info@benvenuemedical.com.
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This article is sponsored by Benvenue Medical.