FDA Panel to Discuss Medtronic’s Spinal Stabilization System

The FDA’s Orthopedic and Rehabilitation Devices Panel will meet Feb. 19 to discuss Medtronic’s premarket application for the DIAM spinal stabilization system.

The implantable device is indicated for skeletally mature patients with low back pain secondary to moderate lumbar degenerative disc disease.

DDD is confirmed radiographically with one or more of the following factors:

• Patients must have greater than 2 millimeters of decreased disc height versus the adjacent level;
• Scarring/thickening of the ligamentum flavum, annulus fibrosis or facet joint capsule; or
• Herniated nucleus pulposus.

Read the Federal Register notice here: www.fdanews.com/11-15-FDA-AdCom.pdf. — Jonathon Shacat