TranS1 Receives NICE Guidance for AxiaLIF Approval In UK’s National Health System

TranS1, a spine technology developer that pioneered the anterior retroperitoneal presacral approach utilizing the AxiaLIF System, announced that the UK’s National Institute for Health and Care Excellence (NICE) published its Interventional Procedure Guidance recommendation for transaxial interbody lumbosacral fusion for severe chronic low back pain.¹ The guidance recommended that the procedure be available to properly indicated patients in the UK’s National Health System (NHS). This recommendation places TranS1’s presacral approach and AxiaLIF System in the same ‘standard arrangements’ category as other widely used MIS technologies such as Lateral Lumbar Interbody Fusion (LLIF) and MIS SI Joint Fusion.
 
NICE develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations. NICE’s role is to improve outcomes for people using the NHS and other public health services².
 
TranS1’s AxiaLIF (Axial Lumbar Interbody Fusion) System is a minimally invasive spinal fusion option designed to create a safe anterior retroperitoneal presacral pathway to the L5-S1 segment without the destabilizing muscle and ligament damage associated with traditional anterior or posterior lumbosacral fusion techniques. Citing potential benefits of the presacral approach including “faster recovery and less postoperative morbidity compared to conventional spinal fusion surgery,” NICE based its guidance recommendation on a comprehensive literature search and detailed review process¹.
 
“The ‘standard arrangement’ recommendation by NICE only further solidifies that the AxiaLIF technology is not investigational or experimental and is a viable treatment option for surgeons and their patients not only in the UK but worldwide,” said John D. Miller, president & CEO of TranS1. “Our AxiaLIF System is an important foundational element of our business that we plan to leverage as we execute on our reimbursement strategy.”
 
References
¹ NICE Interventional Procedures Guidance [IPG620]. July 2018. https://www.nice.org.uk/guidance/ipg620/chapter/1-Recommendations
² https://www.nice.org.uk/about/who-we-are/our-charter