Issue link: https://beckershealthcare.uberflip.com/i/1027775
Combine the pain relief of a decompression and the clinical outcomes of a fusion while preserving lumbar motion with coflex is the exclusive posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability Statistically Superior Compared to Decompression Aloneˆ 10% 20% 30% 40% 50% 60% 70% *p=(0.017) 0 58.4% 41.7% Composite Clinical Success at 24 Months Decompression with coflex Decompression Alone 5x improvement in walking distance 3.3x less epidural steroid injections Superior maintenance of foraminal & posterior disc height ESCADA European Study of coflex and Decompression Alone coflex Increases Walking Distance, Maintains Foraminal Height, and Decreases Compensatory Pain Management Maintains Motion at Operative and Adjacent Segments* US FDA STUDY 5 4 6 7 8 3 2 1 ROM at Operative Level and Level Above coflex ® Level Above coflex ® Operative Level Pre-op 6W 12M 24M 36M 48M 60M degrees Non-inferiority to fusion out to 5 years Composite Clinical Success° consistently higher compared to fusion Foraminal height, disc height & range of motion maintained to 5 years coflex is a Viable Alternative to Traditional Decompression and Fusion Composite Clinical Success at 24 Months Percentage of Patients Achieving Success degrees Maintains Motion at Operative and Adjacent Segments Decompression with coflex Decompression Alone 70% 60% 50% 40% 30% 20% 10% 0 Pre-op 6W 12M 60M 48M 36M 24M coflex Operative Level coflex Level Above 8 7 6 5 4 3 2 1 ^ For Composite Clinical Success (CCS) at 2 years (p=0.017). Claims based on ESCADA data, published in Journal of Neurosurgery: Spine. Volume 28 Issue 4, April 2018. *Claims based on FDA PMA P110008, October 2012; a randomized FDA clinical study comparing the coflex ® Interlaminar Stabilization ® device to pedicle screw fusion surgery for moderate to severe spinal stenosis. All data on file at Paradigm Spine, LLC. °CCS is a binary outcome measure in which all 4 components must be achieved: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions or lumbar injections; 3) neurological maintenance or improvement without worsening; and 4) no device- or procedure-related severe adverse events. coflex ® and Interlaminar Stabilization ® are registered trademarks of Paradigm Spine, LLC. © 2018 Paradigm Spine, LLC. All Rights Reserved. www.paradigmspine.com | www.coflexsolution.com coflex is the first and only lumbar spinal device with Level I Evidence in two prospective, randomized clinical studies, against two standard treatments (decompression alone and fusion), across two countries Attending the NASS show in Los Angeles, CA September 26 - 29, 2018? Visit Paradigm Spine Booth #1429 Paradigm Spine_Beckers Spine August 2018.indd 1 7/24/18 6:32 PM