You are here

Home » » Archives

2020

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

Submitted by Content Manager on Mon, 09/21/2020 - 9:42am
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

Submitted by Content Manager on Mon, 10/05/2020 - 4:43pm
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...

One-Year Outcomes Data from the OptiMesh® SCOUT (Spineology® Clinical Outcomes Trial) IDE (Investigational Device Exemption) Published in SPINE

Submitted by Content Manager on Tue, 11/24/2020 - 2:36pm
The OptiMesh ® Expandable Interbody Fusion System demonstrates significant reduction in pain, improvement in back function, and high patient-satisfaction scores ST. PAUL, Minn.--( BUSINESS WIRE )-- Spineology Inc. , an innovator in anatomy-conserving surgery, announces that one-year outcomes data of its Spineology® Clinical Outcomes Trial (SCOUT) has been published online in SPINE, the journal of the North American Spine Society. The article, "One Year Outcomes from a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device,” focuses on trial outcomes of patients treated with the OptiMesh Expandable Interbody Fusion System. The unique OptiMesh device expands in...