Clinically Effective
- 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
Scientifically Proven
- 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
Cost Efficient
- 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
Patient Compliance
- 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.
INDICATIONS
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.
USAGE
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.
CONTRAINDICATIONS
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.