Overview
About the Device
Electrical stimulation of the spine is the application of an external, electric treatment signal that helps promote the body’s own natural healing process following a spinal fusion.
A spine fusion stimulator is sometimes used to help the body heal; especially if a patient has specific risk factors or an underlying medical condition that may compromise normal healing.
Effective
- In one clinical study for posterolateral fusions, the SpinalPak Stimulator System 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 SpinalPak group vs. 64.9% in the placebo group (P=0.004).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,**
Resources
Manuals
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System Complete Manual and Package Insert Physician Manual
PN# 1067795-00 Rev. G, ZV1184 REV B 01/24Download PDFBiomet® SpinalPak® Non-invasive Spine Fusion Stimulator System Patient Manual
PN# 1067796-00 Rev. G, ZV1058 REV B 01/24Download PDF
Product Features
How It Works
The SpinalPak Stimulator System works by sending low level electrical impulses directly to the spine fusion site via a pair of lightweight, disposable electrodes. The electrodes are placed 2-3 inches on either side of the fusion sight. 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 SpinalPak 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
How can a patient be prescribed a SpinalPak Stimulator System?
The patient has a pacemaker. Can they be prescribed a SpinalPak Stimulator System?
Can a patient be prescribed a SpinalPak Stimulator System while wearing a back brace over their fusion site?
Is the system MRI safe?
Is the system safe to use during pregnancy?
Will insurance cover the cost of the device?
Who should the patient contact if they have questions or need to order supplies?
Zimmer Biomet Customer Care Representatives are ready to answer questions and can be reached at 1-800-526-2579 extension 6000.
Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day.
Benefits
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System
Following lumbar spine fusion surgery, the SpinalPak Stimulator System may be prescribed. The SpinalPak 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 on either side of the fusion 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 SpinalPak Stimulator System is easy to use, portable and battery operated.
- The device is a small, lightweight non-invasive spinal fusion stimulator which allows patients to treat while going about their daily routine.
- The Soft-Touch® electrodes can be comfortably worn under a brace.
- Compliance monitoring consistently tracks your treatment progress.
- Nearly 490,000 patients have been treated with the SpinalPak Stimulator System.4
- The SpinalPak Stimulator System is FDA approved and has more than 30 years of clinical use.5
Videos
Important Product Information
INDICATIONS: The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is a noninvasive 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 – Not for Re-Sale or Re-Distribution – Do Not Reuse.
CONTRAINDICATIONS: There are no known contraindications regarding the use of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System.
WARNINGS: The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active Biomet SpinalPak Non-invasive Spine Fusion Stimulator System device. If there are any observable adverse changes in the pacemaker rhythm or output, the device should not be used.
The safety and effectiveness of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with the device.
PRECAUTIONS: The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System has not been studied in individuals with the following conditions: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of the lumbar spine and osteoporosis: therefore, the safety and effectiveness of the device in these individuals is unknown.
For complete prescribing information including warnings and precautions, please refer to the Biomet SpinalPak Non-invasive Spine Fusion Stimulator 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.
EBI, a Highridge Company
EBI, a Highridge Company
1 Gatehall Dr. Suite 303, Parsippany, NJ 07054
USA: 1-800-377-5804
If you have any questions about Bone Healing products, please call our 24/7 hotline at 1-800-377-5804.
Report A Product Complaint
Customer Service Line: 1-800-526-2579 x 6000
Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day.
Additional Information
References
- 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.
- 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.
- 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.
- Data on File at Zimmer Biomet – ZBDATA1_20
- Data on File at Zimmer Biomet – P850022
*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. The radiological and clinical success rate for posterior lateral fusion together are 89.1%
**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