• Biomet? SpinalPak? Non-invasive Spine Fusion Stimulator System

    Effective

    • In one clinical study for posterolateral fusions, the SpinalPak stimulator demonstrated clinical or radiological healing outcomes as high as 92.7%1,*
    • For lumbar spinal fusions, overall success rate (clinical and radiographic) was 84.7% in the Spinal Pak group vs. 64.9% in the placebo group (P=0.0043)1
      • In posterolateral fusions, the success rate was?89.1%?in the SpinalPak group vs. 64.9% in the placebo group (P=0.006)1

    Scientifically Proven

    • In one?in vitro?pre-clinical study, upregulation of multiple bone morphogenetic proteins (BMPs) was shown to occur with capacitive coupling (CC) stimulation in as little as?30 minutes?of exposure with optimal upregulation occurring at 24 hours 2,**
    • In another pre-clinical study, capacitive coupling (CC) stimulation was shown to cause significantly higher levels of cellular proliferation than other electrical stimulation technologies, including combined magnetic fields (CMF) and pulsed electromagnetic fields (PEMF)3,**

    An Established Product

    • Nearly?400,000?SpinalPak Stimulator Systems sold4
    • More than?30 years?of proven clinical use5

    Designed with Patients in Mind

    • Smallest?and?lightest?electrical stimulation device on the market6
      • Lightweight electrodes weigh less than an ounce allowing for minimal weight around the fusion site, and can be comfortably worn under a brace
    • Compliance monitoring software – The SpinalPak stimulator contains embedded software that displays patient treatment data. This data may be downloaded to a health care professional’s computer for reviewing, storage or printout, via the use of the Patient Compliance Data Download Software7

    Indications
    The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is a non-invasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels - P850022/S017.

    Usage
    The SpinalPak Non-invasive Spine Fusion Stimulator System is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only - Prescription Only - Single Patient Use Only - Do Not Reuse.

    Contraindications
    There are no known contraindications regarding the use of the Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System.

    For complete prescribing information including warnings and precautions, please refer to the Biomet SpinalPak Non-invasive Spine Fusion System Complete Manual and Package Insert or the Patient Manual PN1067795-00 or PN1067796-00 or call 1-800-526-2579 extension 6000.

    Financial Disclaimer

    In support of their research for or preparation of this work, one or more of the authors may have received remuneration from Zimmer Biomet.

    1. Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions.?Spine.?1999;24(13):1349-1356.
    2. Wang Z, Clark CC, Brighton CT. Up-regulation of bone morphogenetic proteins in cultured murine bone cells with use of specific electric fields.?J Bone Joint Surg Am.?2006;88(5):1053-1065.
    3. Brighton CT, Wang W, Seldes R, Zhang G, Pollack SR. Signal transduction in electrically stimulated bone cells.?J Bone Joint Surg Am.?2001;83-A (10):1514-1523.
    4. Data on File at Zimmer Biomet – ZBDATA1_20
    5. Data on File at Zimmer Biomet – P850022
    6. Data on file at Zimmer Biomet?– P&R17341A?
    7. Compliance Data Download Software User Manual?– PN 1067778-01

    ?

    *Represents the radiological or clinical success rate for posterolateral fusion separately. Radiological results P=0.013; clinical results P=0.088.?P values for the clinical success rate between 0.05 and 0.10 show a trend toward statistical? significance.

    **Although not indicative of human clinical results, outcomes from pre-clinical research have been implicated in various models of bone repair.

    Legal Manufacturer:

    EBI, LLC d/b/a Zimmer Biomet
    Bone Healing Technologies
    399 Jefferson Road
    Parsippany, NJ 07054 USA


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    This material is intended for health care professionals. ?Distribution to any other recipient is prohibited.
    For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.