FDA Gives Green Light for Clinical Study of Total Spine Arthroplasty System

The U.S. Food and Drug Administration (FDA) has granted conditional approval to Flexuspine Inc. to begin the first phase of a clinical study for a total spine arthroplasty system. This is the first study of its kind in the United States, according to the Pittsburgh, Pa.-headquartered firm.

Flexuspine’s FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by re-establishing mobility in an affected segment of the lumbar spine, according to the company. The device is composed of an interbody disc component and posterior dynamic resistance component 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 Louis Nel Jr., M.D.’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,” said Nel.

Erik Wagner, chief technical officer, said: “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 facets, and is designed to achieve segmental reconstruction from a single posterior approach,”

Flexuspine plans to begin patient enrollment in the U.S. feasibility study soon while continuing to establish similar clinical study sites in several countries outside the United States, according to company officials.