SurGenTec’s ION-C facet fixation system, an implantable screw used to stabilise the posterior cervical spine’s (neck) facet joints during spinal fusion procedures, has received an expanded indication from the US Food and Drug Administration (FDA) for use in cervical pseudoarthrosis treatment.
Cervical pseudoarthrosis occurs when a previous neck fusion fails to heal properly. Inadequate surgical technique and fixture, or preexisting patient conditions such as osteoporosis, poor nutrition, or a history of smoking that results in restricted blood flow in the neck region, can make the failure of a neck fusion more likely.
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The Florida-based company’s indication expansion for ION-C means that it can be used in corrective or revision surgeries to stabilise the neck’s facet joints, to maintain alignment and improve a surgery’s chances of success.
In the US, anterior cervical discectomy and fusion (ACDF) is the most common type of neck fusion, with around 130,000 individuals undergoing the procedure each year.
Research indicates that cervical pseudoarthrosis, which results in nerve compression, pain and numbness in other areas of the body such as the arms and back, is the driving force behind 45%-56% of neck revision procedures.
The expanded indication was granted on the basis of results from a study that was approved by an Institutional Review Board (IRB).
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By GlobalDataIn assessing the safety and efficacy of ION-C, when implanted bilaterally within the facet joints, , the study demonstrated the bridging of bone across the facet joints, with no reported adverse events, implant migration, or revision surgeries reported during the study period. Imaging was used to evaluate fusion and segmental motion.
“ION-C demonstrates our commitment to delivering cutting-edge solutions that empower physicians with advanced options to treat their patients,” said SurGenTec’s CEO Travis Greenhalgh.
“Maintaining native alignment and curvature is critical in spine surgery. ION-C has demonstrated long-term fusion success while preserving the facet joints in a neutral position and minimising the risk of joint expansion that can lead to postoperative kyphosis,” Greenhalgh continued.
According to GlobalData analysis, the spinal fusion market is growing at a CAGR of 2.3% and projected to be worth around $17.4bn in 2034, up from around $14.87bn in 2024.
Companies including Neo Medical are developing augmented reality (AR) and virtual reality (VR) solutions to help better plan for various spinal surgeries and reduce the incidence of fusion failures and the need for revision surgery.
