Applied Spine Technologies (AST), Inc. announced that US FDA has granted permission to proceed with enrollment in their IDE trial of the Stabilimax NZ Dynamic Spine Stabilization System.
The trial starts again after AST voluntarily suspended enrollment in August 2008. AST suspended the enrollment due to three reports of screw fracture. Changes to the surface finishing technique were recommended and implemented after collaborating with Exponent, Inc. The result was a significant increase in the longevity under fatigue loading of the screw according to testing data.
Recently appointed President and CEO Craig Corrance said, “Voluntary suspension of enrollment late last year was the correct decision to make and management showed terrific fortitude in making that decision. AST is now eager to resume patient enrollment and we look forward to building upon the impressive results we have obtained so far.”
Clinical Investigator Neel Anand, M.D. agrees, stating “I am most pleased to commence with re-enrollment. The Stabilimax NZ system has the potential to address an important sector within the degenerative lumbar spine segment. Preserving motion while reducing pain, and offsetting the risk of future adjacent level symptoms, is an attractive proposition for both patient and physician.”