NuVasive (San Diego), focused on developing products for minimally disruptive surgical treatments for the spine, reported that it filed for an investigational device exemption (IDE) from the FDA to investigate the safety and efficacy of its Cerpass cervical Total Disc Replacement (TDR) product.
TDR replaces a damaged or degenerative spinal disc and allows for flexibility in that space by retaining the normal biomechanics of the spine and preserving natural range of motion, NuVasive said. Traditional fusion procedures replace the disc with implants that bridge the space and facilitate new bone growth to eliminate motion.
NuVasive’s Cerpass cervical TDR product incorporates a ceramic-on-ceramic design that the company said increases durability and eliminates the potential problems of wear debris from other bearing surfaces, such as polyethylene. In preclinical testing, the Cerpass compared favorably to other artificial spinal discs currently in FDA clinical studies, the company said. Cerpass also is designed to ensure proper placement with its “self-centering” feature. Cerpass is designed for implantation through an anterior approach to the cervical region of the spine.
“The IDE filing for U.S. clinical trials of our Cerpass cervical TDR product represents a major milestone in NuVasive’s artificial disc development efforts for motion preservation of the neck vertebrae,” said Chairman and CEO Alexis Lukianov. “We believe the ceramic-on-ceramic design will achieve superior long-term wear characteristics compared to that of other bearing surfaces.”
Lukianov said the company’s initial TDR focus continues to be on the cervical region of the spine. “We believe it offers a more substantial market opportunity and will experience a broader, more rapid adoption by spine surgeons particularly when coupled with our self-centering feature to simplify implantation,” he said.