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Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
Date:4/22/2010

PITTSBURGH, April 22 /PRNewswire/ -- Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

(Photo:  http://www.newscom.com/cgi-bin/prnh/20100422/NE91456 )

Flexuspine's FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by reestablishing mobility in an affected segment of the lumbar spine. The device is composed of an interbody disc component (Core) and posterior dynamic resistance component (Dampener) and is designed as a system to restore the motion and natural kinematics of the affected spine segment.

The approval process included an extensive review of Flexuspine's research, design and biomechanical testing of the FSU device by the FDA, as well as an assessment of Dr. Louis Nel Jr.'s first-in-man clinical series performed in South Africa.  "This is a much needed next step in spinal arthroplasty.  The potential advantages of this technology could make it the first real 'total' level replacement," commented Dr. Nel.

"The FSU is not like the currently approved disc or facet replacement devices on the market today that only partially rebuild the motion segment.  The FSU has three separate parts working together, similar to healthy discs and
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SOURCE Flexuspine, Inc.
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