Here are five highlights:
1. SCOUT is an investigational device exemption trial testing the company’s OptiMesh deployable graft containment implant.
2. The trial will test the product’s safety and efficacy for lumbar interbody fusion procedures treating degenerative disc disease. Spineology hopes the trial will deliver data supporting a regulatory submission for interbody mesh fusion indications in the U.S.
3. OptiMesh allows the “contained bone graft to conform to the prepared vertebral body endplates,” according to the press release.
4. SCOUT includes 102 patients who have had painful lumbar DDD for at least six months. Boston-based Brigham and Women’s Hospital, Burlington-based University of Vermont, Shreveport-based Spine Institute of Louisiana, Florida Orthopaedic Associates, and Washington, D.C.-based Georgetown University, among others, serve as trial sties.
5. The product received FDA clearance in 2003 for graft containment within the vertebral body.
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