Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the U

PITTSBURGH, April 22 (HSMN NewsFeed) -- 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.

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.

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