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An experimentally validated computer model of the spine implanted with theAFRS(TM) demonstrated reduced stresses in the pedicle screws supporting theimplant. In addition, the results showed improved motion and structuralsupport to the spine.
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"Three inherent characteristics of the AFRS(TM) are thought to contributeto these positive results," stated Professor Goel. "These characteristics are:the anatomic implant design, the unconstrained range of motion, and thereplacement of diseased bone with a cobalt chrome implant. Additional testingwill be conducted to determine the impact that the AFRS(TM) will have on discpressures when implanted in the spine."
When treating patients with low back pain, one of the most importantconcerns for a spine surgeon is how to stabilize the spine after performing aspinal decompression (removal of bone around inflamed nerve roots). In thepast, the only option available was a spinal fusion. However, a fusioneliminates motion and may cause the joints adjacent to the fusion todegenerate more quickly. These concerns lead to the development of motionpreservation devices like dynamic stabilization and facet joint replacement.Dynamic stabilization is an adjunct to fusion and typically utilizes preloadedrods and screws to provide controlled motion. By contrast, facet jointreplacement allows for unconstrained motion and mimics the natural kinematics,balance, and stability in the spine joints; similar to hip and knee jointreplacement devices.
Recent studies have shown that the constrained nature of dynamicstabilization increases screw stresses. This increase may have contributed tothe 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 anunconstrained implant could potentially eliminate the disadvantages of dynamicstabilization.
Eric Bannon, VP of Clinical and Regulatory Affairs, stated, "The AFRS(TM)was designed with the objective of overcoming the inherent weaknesses ofspinal fusion and dynamic stabilization. As a company, we felt it wasimportant to invest in this stringent testing procedure to ensure that theAFRS(TM) would result in positive clinical outcomes. We were pleased to findthat our product outperformed spinal fusion and dynamic stabilization inseveral key areas. The company looks forward to expanding this biomechanicaloutcome data with results from an ongoing FDA approved IDE Study."
The summary findings from this biomechanical testing will be presented atthe Science of Facet Joint Repair and Total Posterior Arthroplasty Symposiumwhich will be held in Austin, Texas at the Omni Hotel on Monday, October 22,2007 at 6:30 PM.
About Facet Solutions
Facet Solutions, Inc. is a privately held, venture backed company that isfocused on developing and commercializing surgical devices for the treatmentof facet related spinal disorders. Facet Solutions has received venturecapital from its partners De Novo Ventures, Pequot Ventures, and Spray VenturePartners. Facet Solutions is FDA registered and is certified to ISO 13485.* Note: AFRS(TM) is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.
SOURCE Facet Solutions
