Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System
- Heal rates as high as 83.3%1
- 60% improvement over placebo in a double-blind study2
- More than 25 years of physician use1
- 75% of Biomet customers are repeat prescribers3
- Pre-clinical studies have shown that Capacitive Coupling causes significantly higher levels of cellular proliferation than other electrical stimulation technologies4
- In vitro pre-clinical studies have shown upregulation of multiple BMPs in as little as 30 minutes of exposure with optimal upregulation at 24 hours of exposure5
- According to a published, peer-reviewed study, electrical stimulation was shown to be more cost efficient when compared to no stimulation or LIPUS for the treatment of nonunions6
- Smallest and lightest bone growth stimulation device on the market, designed with active patients in mind7
- 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.
The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing - P850022/S017.
All OrthoPak® Bone Growth Stimulator Systems are 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.
The use of these device systems is contraindicated if the individual has synovial pseudarthrosis.
For complete prescribing information including success rates, warnings, and precautions, please visit www.biomet.com/stimmanuals or call 1.800.526.2579.
- Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System (P850022/S017) indications for use and risk statement listed below.
- Scott, G. and King, J.B. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg Am, 1994. 76(6): p. 820-6.*
- Data on file at Biomet Spine & Bone Healing Technologies
- 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. Disclaimer: In support of their research for or preparation of this work, one or more of the authors received, in any one year, funding or grants from Biomet, EBI, LLC or Biolectron, Inc. 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.*
- 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.*
- Burden of Illness among Patients Experiencing Bone Fracture Nonunion report, Prepared by Ning Wu, PhD, Yuan-Chi Daisy Lee, MS, Alan Wang, BS, Luke Boulanger, MA, MBA, United BioSource Corporation Copy on file at BS&BHT. Disclaimer: Funding for this study was provided by EBI, LLC, d/b/a Biomet Spine and Bone Healing Technologies
- Physical Weight of the Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System on file at Biomet