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Tenon(R) Medical Announces First Peer Reviewed Publication of the MAINSAIL(TM) Study Analyzing the First 33 Consecutive Patients from an IRB Approved, Prospective, Multi-Centered, Post-Market Clinical Investigation Utilizing the Catamaran(R) SI Joint ...
Tenon(R) Medical Announces First Peer Reviewed Publication of the MAINSAIL(TM) Study Analyzing the First 33 Consecutive Patients from an IRB Approved,
About this update from Tenon Medical, Inc.
[{"type":"text","content":"Tenon(R) Medical Announces First Peer Reviewed Publication of the MAINSAIL(TM) Study Analyzing the First 33 Consecutive Patients from an IRB Approved, Prospective, Multi-Centered, Post-Market Clinical Investigation Utilizing the Catamaran(R) SI Joint Fusion System \n ~ Interim Patient Outcomes Demonstrate Significant Improvements in Pain (VAS) and Disability (ODI), Along with High Patient Satisfaction and Safety Profile at Primary 6-month Analysis ~~ Preliminary SI Joint Fusion Results Based on Independent Radiologist Review Indicate Evidence of Fusion at 12-Months Post-Procedure ~LOS GATOS, CA / ACCESSWIRE / September 4, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) (\"Tenon\" or the \"Company\"), a company transforming care for patients suffering with certain Sacroiliac Joint (SIJ) disorders, today announced the first publication of the Catamaran SI Joint Fusion System® MAINSAIL™ study. This study is an ongoing prospective, single-arm, multi-center, post-market study evaluating clinical and radiographic outcomes of adult patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. The target enrollment for this study is up to 50 patients with up to 24-month follow-up.Literature estimates that the sacroiliac joint contributes to 15%-38% of lower back pain cases, a leading cause of global disability [1,2,3,4]. Non-surgical treatment options for SI joint dysfunction include physical therapy, pain management and therapeutic pain injections. However, when these treatments fail to provide relief, minimally invasive SI joint surgery can be a viable option to relieve painful symptoms and improve patient quality of life.This interim analysis presents early experiences of the first 33 consecutive patients treated with the Catamaran SI Joint Fusion System across six US clinical sites, with primary and secondary clinical endpoint analysis at 6 months and radiographic CT fusion assessment, performed by an independent radiologist.Notable outcomes from this interim analysis include the following:Statistically Significant Reduction in SIJ Pain (VAS) and Disability (ODI) Scoring at 6 months:Mean VAS SIJ pain intensity scores (0-100) significantly decreased from pre-operative levels of 80.9mm to 31.1mm (p","length":2625,"tagName":"div"}]