FDA has granted conditional approval to Flexuspine to begin the initial phase of investigational device exemption (IDE) for a feasibility study of its Functional Spinal Unit (FSU) device. The company claimed that it is the first approved clinical study for a Total Spine Arthroplasty system in the US.
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 clinical series performed in South Africa.
Flexuspine said that it is planing to begin patient enrollment in the US feasibility study soon while continuing to establish similar clinical study sites in several countries outside the US. The goal of the international studies was, and still is, to collect additional data that may be used in support of a US Pivotal Clinical Trial.
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.”
Vincent Jannetty, president and CEO of Flexuspine, said: “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.
“We also just recently received multiple ‘notices of allowance of claims’ from the US Patent and Trademark Office. We are very pleased that the claims cover both the system and key features of the product. The recognition by the patent office of the novelty of the system along with the launch of the clinical study, create the solid business foundation we have been working towards.”