Addison, Texas-based CTL Amedica Corporation launched the RODIN Transforaminal Expandable Lumbar Interbody Fusion System at the recently concluded 2021 North American Spine Society annual meeting in Boston.
Henry Fabian Jr., M.D., M.B.A., is RODIN’s product designer. He holds a graduate degree in biomedical engineering and served as the team physician for the U.S. Ski Association Men’s Alpine Ski Team, Steamboat Springs Winter Sports Club, Cleveland Crunch National Pro Soccer League, and Cleveland Lumberjacks IHL Pro League, among others.
When OTW asked how RODIN distinguishes itself, Dr. Fabian explained, “The RODIN stands apart from its competitors for many reasons but the most important are its superior biomechanical features. As the only expandable lumbar interbody on the market with true load-sharing capability, it has a compressive stiffness significantly less than any traditional, static cage on the market with over 40% less chance of subsidence.”
“It offers superior vertebral body endplate coverage, maximizes graft to host bone surface area and graft volumes, with a footprint equivalent to an Anterior Lumbar Interbody Fusion. It accomplishes all this and still is deliverable through an 8-10mm annulotomy, for true MIS [minimally invasive surgery] application, yet yielding an Anterior Lumbar Interbody Fusion footprint when deployed.”
“The instrumentation and insertion technique are intuitive and any surgeon comfortable with a traditional PLIF/TLIF approach will find no need to change their approach. The surgeon inserts the non-deployed less than 7mm wide RODIN as they would an industry standard 10-12mm spacer and expands in situ, safely in the disc space, to a 25mm X 30mm fully expanded size. Graft can be pre- and post-packed, with post-packing done with rapid succession use of pre-loaded MIS graft tubes that can deliver 8-12cc of graft material in under 60 seconds.”
“The RODIN product features have been rigorously substantiated in over 150 implantations, with zero subsidence, migration or hardware failure issues. Almost all of these have over 2-year follow-up, with multiple patients followed out greater than 4 years. In all those years there has been only one pseudarthrosis, a testament to, and validation of, the superior biomechanics of the design.”
“There has been a flurry of activity in the spine industry focused on hyperlordotic and vertically expandable interbody spacers, with many reported failures. None of these issues are all that surprising, given that vertically expanding and hyperlordotic spacers violate basic biomechanical principles. We’ve known for years that an implant with less than 30% vertebral body endplate coverage is prone to subsidence. Hyperlordotic spacers are only lordotic if the proper orientation of the implant on insertion is achieved, which is actually quite rare. So now we’re left with implants that really don’t work and set the surgeon up for failure. RODIN avoids the ’gimmicky’ approach and completely fulfills time-tested and fundamental biomechanical requirements for a successful fusion.”
Finally, said Dr. Fabian, “Developing the RODIN system was a long process, primarily because achieving what we set out to do was anatomically and technically very challenging. There is a reason why many in the industry defaulted to vertical expandable and hyperlordotic offerings. It is because those approaches are much easier to achieve! No one wanted to go down the rabbit hole of a true horizontal expandable implant because it was deemed too hard, but the end result is the holy grail of lumbar fusion surgery.”
“An implant that can be delivered through a less than 8-10mm annulotomy and then expanded to a footprint as big as an Anterior Lumbar Interbody Fusion, with superior load-sharing and graft delivery, is what surgeons universally desire. One ‘accidental eureka’ moment in the development of RODIN involved the notorious issue of graft delivery to the contralateral posterior area of the disc space.”
“Getting there and grafting that area has been discussed for years. It turns out that when the RODIN deploys, its mobile posterior limbs move graft ‘a la window wiper’ to that area, assisting in bone grafting that region. Maybe this isn’t as exciting as Thomas Edison’s magic moment with the lightbulb, but it may be as close as a spine surgeon gets.”
