NuVasive To Study Safety Of Cervical Product
San Diego, CA — July 6, 2005 — NuVasive, Inc. announced that it filed for an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to investigate the safety and efficacy of its Cerpass cervical Total Disc Replacement (TDR) product on June 30, 2005 as planned. Approval of the IDE from the FDA would allow the Company to initiate a pivotal human clinical study of the device in the U.S.
TDR replaces a damaged or degenerative diseased spinal disc and allows for flexibility in that space by retaining the normal biomechanics of the spine and preserving natural range of motion versus the traditional fusion procedures which 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 believes increases durability and eliminates the potential problems of wear debris from other bearing surfaces such as polyethylene. In pre-clinical testing, the Cerpass compared favorably to other artificial spinal discs currently in FDA clinical studies. Cerpass is also designed to ensure proper placement because of its "self-centering" feature. Cerpass is designed for implantation through an anterior approach to the cervical region of the spine (front of the neck).
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "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. We believe the ceramic-on-ceramic design will achieve superior long- term wear characteristics compared to that of other bearing surfaces. Our 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. We plan to discuss the details of the FDA study for our Cerpass following IDE approval."
SOURCE: NuVasive