Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

Clinically Effective

  • Highest overall success rate in lumbar fusions - 84.7% (inclusive of ALIF, PLIF, posterolateral and combo)1
  • 270,000 patients treated to date2
  • 75% of Biomet customers are repeat prescribers2

Scientifically Proven

  • Pre-clinical studies have shown that Capacitive Coupling causes significantly higher levels of cellular proliferation than other electrical stimulation technologies3
  • In vitro pre-clinical studies upregulation of multiple BMPs in as little as 30 minutes of exposure with optimal upregulation at 24 hours of exposure4

Cost Efficient

  • In a double-blind study, patients experienced a 20% improvement over placebo1; use of the device may reduce the need for revision surgery

Patient Compliance

  • Smallest and lightest bone growth stimulation device on the market, designed with active patients in mind5
  • Compliance monitoring, educational resources and Biomet Alerts program

 

*FINANCIAL DISCLAIMER: In support of their research for or preparation of this work, one or more of the authors may have received, in any one year, outside funding or grants from Biomet, EBI, LLC or Biolectron, Inc. 

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

USAGE
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. 

For complete prescribing information including success rates, warnings, and precautions, please visit http://www.biomet.com/stimmanuals or call 1.800.526.2579.

 

  1. Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, and Yuan HA. A Double-Blind Study of Capacitively Coupled Electrical Stimulation as an Adjunct to Lumbar Spinal Fusions. Spine, Vol. 24, No. 13, pp.1349-1356, 1999.*
  2. Data on file at Biomet Spine & Bone Healing Technologies
  3. Wang Z, Clark CC, and Brighton CT. Up-Regulation of Bone Morphogenetic Proteins in Cultured Murine Bone Cells with Use of Specific Electric Fields. J. Bone Joint Surg Am. 88:1053-1065, 2006. Following non invasive electrical stimulation, increases in multiple growth factors have been observed in various pre-clinical in vitro cellular and in vivo animal studies. Although not indicative of human clinical results, these factors have been implicated in various models of bone repair.*
  4. Brighton CT, Wang W, Seldes R, Zhang G and Pollack SR. Signal transduction in electrically stimulated bone cells. J Bone Joint Surg Am 83A(10):1514-23, 2001. Disclaimer: Following non invasive electrical stimulation, increases in multiple growth factors have been observed in various pre-clinical in vitro cellular and in vivo animal studies. Although not indicative of human clinical results, these factors have been implicated in various models of bone repair.*
  5. Physical Weight of the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System on file at Biomet 

 

 

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
310 Interlocken Parkway #120
Broomfield, CO 80021


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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.