The differentiating aspect of the SpheRx DBR system is its ability to perform "instrument free" compression. Instrument free compression allows the spine surgeon to easily apply up to 5mm of compression by simply moving the DBR Guides with his hands. This elimination of the need for additional bulky or awkward instruments during compression in spinal fixation surgery is unmatched in the industry today.
SpheRx DBR offers maximum overall simplicity of use, keeping with the company's philosophy of developing breakthrough products based on familiar spine surgery instrumentation. The product design allows for a simple, constrained rod insertion achieved through a dual ball rod with spherical ends, which are geometrically constrained within the DBR Guides during rod insertion, guiding the rod directly and easily into the heads of the pedicle screws. The spherical ends of the rod fit securely within the screws at both ends of the construct with no rod overhang, reducing the incidence of superior facet joint violation and tissue trauma. This unique, secure fit also provides the surgeon total confidence the rod is seated properly in the screws and eliminates the possibility of post-operative rod migration.
SpheRx DBR is also designed to be seamlessly integrated with the company's NeuroVision Nerve Avoidance System. Sequentially dilating insulators allow for dynamic stimulation and nerve monitoring during every step of the procedure, from K-Wire insertion and tapping, to screw insertion and compression.
Alexis V. Lukianov, Chairman and Chief Executive Officer, stated: "We believe the SpheRx DBR is quite possibly the most straightforward minimally disruptive fixation system available today. Surgeon feedback has been excellent and endorses the superiority of the product over what has been available on the market. We are very excited about the launch and believe that the many competitive advantages this new percutaneous pedicle screw offers will drive robust adoption and enhance revenues."
John Regan, M.D., Orthopaedic Spine Surgeon, Cedars Sinai Medical Center, stated: "Unlike other minimally invasive pedicle screw systems where the smallest amount of compression was difficult to attain, DBR enables needed compression similar to that of open surgery without additional instrumentation."
Frank Phillips, M.D., Professor, Orthopaedic Surgery, Rush University Medical Center, stated: "With no rod overhang superiorly or inferiorly the potential for adjacent facet impingement is essentially eliminated." William Taylor, M.D., Associate Clinical Professor, UCSD Division of Neurosurgery, added: "By constraining the spherical ends of the rods in the guide, rod placement becomes very reproducible and predictable."
NuVasive is a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. Its product portfolio is focused on applications in the over $2 billion United States spine fusion market. Its current principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS, as well as classic fusion implants.
The MAS platform offers advantages for both patients and surgeons such as reduced surgery and hospitalization time and faster recovery. MAS combines three categories of NuVasive's current product offerings: NeuroVision, a proprietary software-driven nerve avoidance system; MaXcess, a unique split-blade design retraction system; and specialized implants, like SpheRx and CoRoent that collectively minimize soft tissue disruption during spine surgery while allowing maximum visualization and surgical reproducibility. The company's classic fusion portfolio is comprised predominantly of proprietary saline packaged bone allografts and metal mesh cages.
NuVasive also has a robust R&D pipeline emphasizing both MAS and motion preservation products such as Total Disc Replacement (TDR). More company news is available in the VMW July 2004 article NuVasive introduces new treatment advance for spine surgery at UCSD Medical Center.