LOGAN, Utah, Oct. 22 /PRNewswire/ -- Facet Solutions, Inc. announced today that testing conducted by Professor Vijay Goel, PhD., from the Department of Bioengineering at the University of Toledo, demonstrated that the Anatomic Facet Replacement System (AFRS(TM)) has shown biomechanical advantages when compared to dynamic stabilization devices. The objective of the testing was to compare the range of motion, pedicle screw stresses, and spinal stability of facet joint replacement versus dynamic stabilization devices.
An experimentally validated computer model of the spine implanted with the AFRS(TM) demonstrated reduced stresses in the pedicle screws supporting the implant. In addition, the results showed improved motion and structural support to the spine.
"Three inherent characteristics of the AFRS(TM) are thought to contribute to these positive results," stated Professor Goel. "These characteristics are: the anatomic implant design, the unconstrained range of motion, and the replacement of diseased bone with a cobalt chrome implant. Additional testing will be conducted to determine the impact that the AFRS(TM) will have on disc pressures when implanted in the spine."
When treating patients with low back pain, one of the most important concerns for a spine surgeon is how to stabilize the spine after performing a spinal decompression (removal of bone around inflamed nerve roots). In the past, the only option available was a spinal fusion. However, a fusion eliminates motion and may cause the joints adjacent to the fusion to degenerate more quickly. These concerns lead to the development of motion preservation devices like dynamic stabilization and facet joint replacement. Dynamic stabilization is an adjunct to fusion and typically utilizes preloaded rods and screws to provide controlled motion. By contrast, facet joint replacement allows for unconstrained motion and mimics the natural kinematics, balance, and stability in the spine joints; similar to hip and knee joint replacement devices.
Recent studies have shown that the constrained nature of dynamic stabilization increases screw stresses. This increase may have contributed to the higher rates of screw loosening and resulted in limited range of motion. The objective of the biomechanical testing was to determine if the use of an unconstrained implant could potentially eliminate the disadvantages of dynamic stabilization.
Eric Bannon, VP of Clinical and Regulatory Affairs, stated, "The AFRS(TM) was designed with the objective of overcoming the inherent weaknesses of spinal fusion and dynamic stabilization. As a company, we felt it was important to invest in this stringent testing procedure to ensure that the AFRS(TM) would result in positive clinical outcomes. We were pleased to find that our product outperformed spinal fusion and dynamic stabilization in several key areas. The company looks forward to expanding this biomechanical outcome data with results from an ongoing FDA approved IDE Study."
The summary findings from this biomechanical testing will be presented at the Science of Facet Joint Repair and Total Posterior Arthroplasty Symposium which will be held in Austin, Texas at the Omni Hotel on Monday, October 22, 2007 at 6:30 PM.
* Note: AFRS(TM) is an investigational device in the United States. It is
limited by United States (U.S.) Federal Law for investigational use
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. Facet Solutions has received venture capital from its partners De Novo Ventures, Pequot Ventures, and Spray Venture Partners. Facet Solutions is FDA registered and is certified to ISO 13485.
|SOURCE Facet Solutions|
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