The Vertiflex Procedure is supported by a rigorous body of clinical and real-world evidence demonstrating its safety and efficacy. 470 patients were enrolled in an Investigational Device Exemption or IDE trial at 29 sites with a 24-month follow-up and annually thereafter through 60 months. An IDE is a study to collect safety and effectiveness data prior to submission for FDA approval. The data suggests significant relief from the symptoms of spinal stenosis is achievable, along with very high patient satisfaction rate.
Data results at 5-years from patients in the clinical trial *
75% of patients experienced reduction in leg pain
80% of patients experienced improvement in physical function
