TranS1 has announced that its axial lumbar interbody fusion (AxiaLIF) procedure has been shown to provide estimated savings of US$3,500 compared to transforaminal lumber interbody fusion (TLIF), according to an economic analysis published in the Journal of Managed Care Medicine. The procedure was associated with shortened hospital stays, lower rates of hospital readmission and a faster return to work. However, the procedure was also associated with a 2.6% higher rate of pseudoarthrosis.
Speaking to Spinal News International, William D Tobler, Mayfield Brain & Spine, Cincinnati, USA, says, “AxiaLIF is truly minimally invasive, and allows the surgeon to complete the fusion using fluoroscopy. Because of its anterior approach to the spine, the procedures do not require an access surgeon to expose and protect the spine.”
The AxiaLIF procedure was commercialised in 2000 by an earlier company—also named TranS1—and received US Food and Drug Administration (FDA) clearance in 2004. The original TranS1 acquired Baxano Surgical in 2013, broadening its output to include surgical instruments. But, the newly-formed company filed for bankruptcy protection two months later. Quandary Medical owner, Jeff Schell, purchased AxiaLIF, marking the beginning of the current TranS1 start-up.
Tobler believes that AxiaLIF has been held back in the past by a misunderstanding of the risks involved in the surgery. “The drawbacks perceived are risks of exposure particularly with risk of bowel injury. Data seems to indicate that the risk in experienced and well-trained hands is extremely minimal,” he tells Spinal News, “The adaptation of this procedure’s more sophisticated approach is a challenge for surgeons, and there is the perception that there are not enough publications and peer reviewed studies. Consequently, insurance companies are resistant to cover the procedure despite the issuance of category one code in 2013. However, the procedure is well-researched, with more than 80 medical studies documenting it.”
Now that AxiaLIF has been given a new lease of life, Tobler believes that uptake of the procedure will increase. “A group of surgeons believe that the procedure is valid and has some unique features that make it the best treatment for some patients. A new generation of surgeons needs to be educated; to look at and understand this technology,” he says. “The fact that it has survived and has not died as of yet is indicative of something good, that works. There are procedures that go by the wayside because they are bad and ineffective. AxiaLIF is not one of them.”