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2020

Spineology® Announces FDA De Novo Grant of Minimally Invasive OptiMesh® Expandable Interbody Fusion System

ST. PAUL, Minn.--( BUSINESS WIRE )-- Spineology Inc. , an innovator in anatomy-conserving surgery, is excited to announce the FDA grant of its proprietary Spineology Interbody Fusion System, now called the OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial. OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through the smallest access in the spine industry. The SCOUT IDE trial outcomes data was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting in...

Spineology Completes Enrollment in Post-Market Study of Novel, Expandable Lateral Implant

Spineology Completes Enrollment in Post-Market Study of Novel, Expandable Lateral Implant Duo™ System Demonstrates Reduced Operative Times, Shorter Hospital Stays, and Improved Clinical Outcomes Compared to Traditional Lateral Surgery ST. PAUL, Minn.--( BUSINESS WIRE )-- Spineology Inc. , an innovator in anatomy-conserving spine surgery, is excited to announce full enrollment of its 200-patient Duo™ Expandable Interbody Fusion (IBF) System Post-Market Study, called RaDical. The RaDical Study is a prospective, Institutional Review Board (IRB)-approved, multi-center lateral interbody fusion study. It follows subjects for two years and measures intraoperative and postoperative metrics along with short- and long-term outcomes in a real-world patient...