TranS1® Announces NICE Guidance for Approval of AxiaLIF® in the UK's National Health System (NHS)

Tuesday, September 18, 2018 General News
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NICE's Positive Recommendation for the Transaxial Interbody Lumbosacral Fusion describing the Anterior Retroperitoneal Presacral Approach is based on AxiaLIF clinical evidence.

WILMINGTON, N.C., Sept. 18, 2018 /PRNewswire/ -- TranS1®, an innovator in spine technology development that pioneered

the anterior retroperitoneal presacral approach utilizing the AxiaLIF® System, announced today 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."

About TranS1®Recently relocated back to its roots in Wilmington, NC - TranS1 is a pioneer in spine technology innovation and is focused on Building Better Pathways™ to the spine.  Since its inception, TranS1 has designed, developed, and commercialized transformational approaches to the spine used by thousands of surgeons to minimize the damage associated with traditional surgical approaches.  TranS1 believes that the process of Building Better Pathways™ to the spine starts with solving true unmet clinical needs and ends with creating a value-based solution for surgeons, patients, and the healthcare system. 

With more than 18,000 AxiaLIF procedures performed in the last 12 years, the 'arthrodesis, presacral interbody technique' is recognized by the American Medical Association (AMA) as a Category 1 CPT code 22586, non-experimental procedure. The AxiaLIF System is the only presacral approach spinal fusion approved by the US Food and Drug Administration (FDA) with over 90 peer reviewed publications citing its safety and efficacy.  For more information, please visit www.TranS1.com or email John Miller at contact@TranS1.com. Please connect with us on LinkedIn, Twitter, & Facebook.

  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

Cision View original content:http://www.prnewswire.com/news-releases/trans1-announces-nice-guidance-for-approval-of-axialif-in-the-uks-national-health-system-nhs-300714035.html

SOURCE TranS1



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