Applied Spine Technologies (AST) , a medical device company focused on motion preservation of the lumbar spine, has announced that it has received permission from the U.S. Food and Drug Administration (FDA) to proceed with enrolment in their IDE trial of the Stabilimax NZ Dynamic Spine Stabilization System.
The trial resumes after AST voluntarily suspended enrollment in August 2008 following three reports of screw fracture. After collaborating with Exponent, an engineering and scientific consulting firm, changes to the surface finishing technique were recommended and implemented. 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 enrolment 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 enrolment and we look forward to building upon the impressive results we have obtained so far.”
Clinical Investigator Neel Anand agrees, stating “I am most pleased to commence with re-enrolment. 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.”
About the IDE clinical trial
Applied Spine Technologies has received permission from the FDA to resume a multicentre, randomised, controlled clinical trial to compare posterior dynamic stabilisation using the Stabilimax NZ Dynamic Spine Stabilization System to traditional spinal fusion stabilisation to treat degenerative lumbar spinal stenosis. AST has enrolled over 100 patients to date.