Facet Solutions, Inc. Receives IDE Approval
Logan, Utah, May 8, 2006. Facet Solutions, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted conditional Investigational Device Exemption (IDE) approval for its Anatomic Facet Replacement System (AFRS™). The approval establishes Facet Solutions as a leader in the posterior spine motion preservation field and clears the way for a U.S. clinical study of its AFRS™.
The AFRS™ has been developed to provide lumbar spinal stenosis and facet degeneration patients with a motion preserving alternative to spinal fusion. The AFRS™ utilizes precision instrumentation and anatomic implants to reconstruct normal facet anatomy, restoring physiological motion and stability to the lumbar spine while allowing the surgeon to alleviate pain.
The IDE process involves an exhaustive, thorough review of all clinical and bench top testing data by the FDA. The rigorous preclinical and clinical evaluation of the AFRS™ gives us great confidence that this implant system will provide a compelling alternative to lumbar fusion for patients in the near future, stated Alan Chervitz, President and CEO of Facet Solutions, Inc.
No other motion preservation device for the posterior lumbar spine has been designed to replicate the natural anatomy of the facet joint, continued Chervitz. The AFRS™ design is based upon a detailed study of facet joint morphology. In other more mature segments of orthopedics such as total hip and total knee replacement, only the designs that replicate the natural joint anatomy have withstood the test of time, stated Chervitz.
Facet Solutions will begin enrolling patients into its U.S. clinical study in the very near future. In addition to the U.S. clinical study, the company will be conducting a clinical study in Europe which is schedule to begin within the next two or three months.
The Facet Solutions technology is the first anatomic facet arthroplasty device to be developed and studied as an advanced treatment for lumber spinal stenosis disease. Lumbar spinal stenosis is the largest and fastest growing segment of the operative lumbar spine market. The AFRS™ holds considerable promise as an alternative to fusion and dynamic stabilization procedures for patients with lumbar spinal stenosis.
About Facet Solutions
Facet Solutions, Inc. is a privately held, venture backed company that is focused on developing and commercializing surgical devices for the treatment of facet related spinal disorders. The company is a MedicineLodge, Inc. spin-out company and they will be attending the upcoming Spine Arthroplasty Society meeting in Montreal, Canada (booth #415).