Electrical Bone Growth Stimulation
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System
About the Device
When a bone fractures, the body produces naturally occurring electrical fields that surround the fractured bone segments to stimulate repair. These naturally occurring internal electrical fields are a critical biological process that is necessary for bone to grow and heal normally.
The purpose in using a bone growth stimulator is to mimic the body’s own natural occurring signaling processes by the application of an external, electric treatment signal for patients who have specific risk factors or an underlying medical condition that may compromise normal healing.
Effective
- The only electrical stimulation device on the market that is FDA approved for 24-hour use to treat nonunion fractures.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,*
Product Features
How it Works
The OrthoPak Stimulator System works by sending low level electrical impulses directly to the nonunion fracture site via a pair of disposable electrodes. Two lightweight electrodes are placed on either side of the fracture nonunion site and positioned 180 degrees apart from each other. The stimulator produces an electrical treatment signal in the area between the electrodes, which helps to mimic the body’s natural healing process.
Recommended Use
The OrthoPak 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. Basic safety precautions should always be followed, including removal of the device prior to showering, bathing or swimming.
Healing outcomes may vary due to health, activity, risk factors or other medical conditions the patient may have. Not all patients are candidates for this medical device, so it’s important to evaluate each patient prior to prescribing the device. Only a qualified healthcare professional can determine the appropriate treatment for each patient.
Frequently Asked Questions
Resources
Benefits
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System
The OrthoPak Stimulator System is a non-invasive, nonsurgical, medical device. The OrthoPak Stimulator System utilizes a unique capacitive coupling technology that is designed to deliver a therapeutic, electrical treatment signal via a pair of disposable electrodes. The Soft-Touch® electrodes that accompany the system are lightweight and easily applied to the skin at the fracture nonunion site. The treatment signal operates at a low-level frequency in which most patients don’t feel anything during treatment; however, some patients have reported feeling a slight, tingling sensation.
- The OrthoPak Stimulator System is easy to use, portable and battery operated.
- The device is a small, lightweight non-invasive bone growth stimulator which allows patients to treat while going about their daily routine.
- The Soft-Touch® electrodes means less weight placed at the fracture nonunion site.
- Compliance monitoring consistently tracks treatment progress.
- Over 100,000 patients have been treated with the OrthoPak Stimulator System.3
- The OrthoPak Stimulator System is FDA approved and has more than 30 years of clinical use.1
Operating the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System
Important Product Information
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 there are no visibly progressive signs of healing – P850022/S017.
USAGE: The OrthoPak Bone Growth 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 - Not for Re-Sale or Re-Distribution - Do Not Reuse.
CONTRAINDICATIONS: The use of this device is contraindicated if the individual has synovial pseudarthrosis.
WARNINGS: Utilization of this stimulator allows full weight bearing on the casted extremity unless gross motion (greater than 5 degrees in any plane) at the nonunion site is present. In such a case, weight bearing is not advised and should not be permitted as this may compromise the effectiveness of the treatment. The safety and effectiveness of the use of the device on individuals lacking skeletal maturity has not been established. Animal safety studies indicate that the device does not interfere with the normal intrinsic activity of the heart. However, the stimulator does interfere with the operation of certain pacemakers. The concomitant use of the device and a pacemaker must be assessed on an individual basis, prior to use (such as with an electrocardiogram).
PRECAUTIONS: Although laboratory teratological studies performed with this device demonstrate no adverse findings, the safety of this device used during pregnancy and nursing in humans has not been established.
For complete prescribing information including contraindications, warnings, and precautions, please refer to the Biomet OrthoPak Non-invasive Bone Growth System Complete Manual and Package Insert or the Patient Manual PN1067799-00 or PN1067800-00 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.