AST to Resume Clinical Trials of Spinal Stabilization Device

lumbarApplied Spine Technologies, a device company dedicated to the treatment of chronic low back pain, has received permission from the U.S. Food and Drug Administration to restart a clinical trial of the Stabilimax NZ Dynamic Spine Stabilization System. The Stabilimax system is designed to stabilize the lumbar spine while still preserving motion.

AST of New Haven, Conn., voluntarily suspended enrollment in an IDE trial last year following three reports of screw fracture. The company collaborated with an engineering firm to solve the problem, and the reworked screws performed significantly better in testing. 

The multi-center clinical trial will compare posterior dynamic stabilization in Stabilimax NZ and traditional spinal fusion surgery in patients with lumbar spinal stenosis.  In spinal stenosis, degeneration in the lumbar spine leads to a narrowing of the spinal canal. This narrowing leads to compression of the nerve roots, causing pain. It is estimated that half a million Americans may suffer from lumbar spinal stenosis.

Other companies developing solutions for degenerative spinal diseases include N Spine, Disc Motion Technologies, Interventional Spine, Spinal Kinetics, and AxioMed Spine.

The comments are closed.