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Flexuspine receives FDA conditional approval for feasibility study of spine arthroplasty system
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Flexuspine, Inc. announced this week that the FDA has granted conditional approval for it to begin the initial phase of an Investigational Device Exemption (IDE) for a feasibility study of its FSU device — the first approved clinical study for a total spine arthroplasty system in the United States, according to a company press release.
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 press release. 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 FDA review of Flexuspine’s research, design and biomechanical testing of the FSU device, as well as an assessment of Louis Nel Jr., MD.’s first-in-vivo 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,” Nel stated in the release.
Erik Wagner, Flexuspine chief technical officer, noted, “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.”
Vincent Jannetty, president and CEO of Flexuspine, commented, “We are extremely proud of reaching this milestone after completing the tremendous amount of work that went into the development of the FSU device. We are moving into this next phase of our business to verify and validate the science and technology behind the product.”
Flexuspine said it plans to begin patient enrollment in the U.S. feasibility study soon while continuing to establish similar clinical study sites in several other countries outside with a goal of collecting additional data that may be used in support of a U.S. pivotal clinical trial.