One-Year Outcomes Data from the OptiMesh® SCOUT (Spineology® Clinical Outcomes Trial) IDE (Investigational Device Exemption) to be Published in SPINE
The OptiMesh® Expandable Interbody Fusion System demonstrates significant reduction in pain, improvement in back function, and high patient satisfaction scores
ST. PAUL, Minn.--Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce that SPINE, the journal of the North American Spine Society, has accepted the manuscript, “One Year Outcomes from a Prospective Multicenter Investigation Device Trial of a Novel Conforming Mesh Interbody Fusion Device,” for publication. The outcomes data for this publication came from SCOUT, a prospective, multicenter investigation device trial of patients treated with the OptiMesh Expandable Interbody Implant. The unique OptiMesh device expands in three dimensions, enabling surgeons to perform interbody fusion procedures through an access smaller than any other fusion procedure. Publication is anticipated before the end of 2020.
SCOUT demonstrated strong outcomes for the OptiMesh implant at one year including:
- Significant reduction in back and leg pain1
- Substantial improvement in functional status that occurred early and was sustained through 12 months1
- 90 percent ‘excellent’ or ‘good’ patient satisfaction scores1
- A 98 percent fusion rate1
- An excellent safety record with no serious, device-related, adverse events1
“We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” said John Chi, M.D., M.P.H., SCOUT’s lead investigator. Dr. Chi is the Director of Neurosurgical Oncology at Brigham and Women’s Hospital in Boston, Massachusetts and Associate Professor of Neurosurgery at Harvard Medical School, and the author of the SPINE article. “The outcomes, including high fusion rates, improved function, reduced pain, and high satisfaction rates, are very favorable. Additionally, the minimal exposure requirements yielded an exceptional safety profile.”
“Spineology recently received an FDA De Novo Grant for the interbody placement of OptiMesh and is preparing for a Q1 2021 launch,” said John Booth, Spineology’s CEO. “Publication of the SCOUT data is further testimony to the strength of the study. The results demonstrated by OptiMesh along with the experiences of our investigators will help take surgery for low back and leg pain to the next level by providing excellent patient outcomes, enhanced recovery, and exceptional efficiency.”
In addition to the SPINE publication, the International Journal of Spine Surgery (IJSS) has accepted three manuscripts discussing Spineology’s proprietary mesh technology. “Load-Share Mapping for Traditional PEEK versus Novel Hybrid PEEK with Expandable Porous Mesh Intervertebral Devices,” “Critical Evaluation of Biomechanical Principles of Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant,” and “Cell and Tissue Response to Polyethylene Terephthalate (PET) Mesh Containing Bone in Vitro and in Vivo.” IJSS will be publishing all three manuscripts in a special issue this fall.
About Spineology Inc.
At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh and Duo implants, which expand in three dimensions to create large footprints and allow placement of anatomy-conforming interbody fusion devices through very small incisions. This technology preserves spinal anatomy, increases procedural efficiency, and accelerates patient recovery. Learn more at spineology.com
John J. Booth, Chief Executive Officer
1 Lu Y, Huang K, Lavoie S, Krag M, Nunley P, Bydon M. Preliminary 24-month Outcomes of a Prospective Investigation of a Novel Mesh Interbody Spacer in Single-Level Fusions. Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2019. Las Vegas, NV. 2019 Oct 31 - Nov 2.