Product Description
Cervical-Stim offers the security of proven, safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients.
It offers the comfort of an external device that patients tell us is the most effortless treatment they have ever experienced. Not to mention the comfort enjoyed with improved clinical outcomes: In a PMA study of 323 high-risk ACDF patients, 84% achieved fusion within six months using Cervical-Stim vs. 69% for those who did not receive treatment.1 Additionally, the data from this study prove for the first time that fusion has a positive effect on VAS and NDI clinical outcomes after ACDF.2
Since 1990, more than 200,000 spine fusion patients have healed with bone growth stimulation from Orthofix. We brought you the first and most effective external bone growth stimulator for lumbar fusion, and now offer you the only FDA approved device to increase the rate of cervical fusion success.
- Comfortably worn during daily activities, with or without a cervical brace, four hours per day
- Proven to overcome risk factors for nonfusion
- Next generation design with smart technology and patient friendly functionality
Indication
The Cervical-Stim is a noninvasive, pulsed electromagnet bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for nonfusion.
Surgeon Benefits
- Safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients
- Smart technology can provide outcomes reports and hardcopy patient compliance monitoring
- Written guarantee for bone growth stimulation products
- The only FDA approved bone growth stimulator for cervical fusion
- Patient friendly, comfortably worn during daily activities with or with a cervical brace, four hours per day
Surgeon Support Materials
Documents:
- Brochure: Frequently Asked Questions About Surgeon Billing for Orthofix Bone Growth Stimulation Products
- Patient Manual
- Surgeon Manual
- Q and A: A Patient's Guide to Bone Growth Stimulation
Videos:
- Spine Products Overview (Flash Presentation 4.1MB)
- Dr. Foley's Presentation - Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with Clinical Outcome
Clinical References
- Randomized, Prospective, Controlled Clinical Trial of Pulsed Electromagnetic Field Full Text Article (PDF 7KB)
- Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with Clinical Outcome Full Text Article (PDF 11KB)
- Pulsed Electromagnetic Field Stimulation Increases Multilevel Cervical Fusion RatesFull Text Article (PDF 19KB)
- Dr. Foley's Presentation - Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with Clinical OutcomeFlash Presentation (Size 1.64MB)
Patient Benefits
- Lightweight, all-in-one unit allows unrestricted patient mobility – no separate cables, control units or battery packs
- Comfortably worn around the neck, with or without a cervical brace, four hours per day
- Patient friendly functionality: Instant information panel with LCDs for ongoing operational status
- Easy buckle for on/off
- Designed for more flexibility and comfort
- Internal countdown shuts off automatically when daily treatment is complete
Patient Support Materials
*Patient manuals are for use outside of the U.S. only – not intended for distribution
| Patient Manuals | |
|---|---|
| Chinese (PDF 8.8MB) | German (PDF 3.8MB) |
| Dutch (PDF 3.8MB) | Italian (PDF 3.8MB) |
| English (PDF 3.8MB) | Spanish (PDF 3.8MB) |
| French (PDF 3.8MB) | Swedish (PDF 3.8MB) |
Additional Documents:
Videos:
Testimonials
My daily experience with Cervical-Stim … you put it around your neck like a scarf, push a button, it comes on, you wear it for four hours, and it goes off, automatically, by itself. It was the easiest therapy and recovery that I had tried ever...and, it worked!
Arianae Miller, clinical trial participant, patient of Dr. Kevin Foley
With Cervical-Stim, bone growth stimulation has now been FDA approved for use in the neck. This is good news for patients who have to undergo a cervical fusion, and it’s good news for their doctors.
Dr. Kevin Foley, lead investigator, Cervical-Stim Clinical Trial, Semmes -Murphy Clinic and Department of Neurosurgery, University of Tennessee
I have been wearing an Orthofix bone growth stimulator for the past several weeks. It is awesome. It is extremely easy to keep on for four hours. I would do this all again in a heartbeat without a second thought. I have undergone all conservative testing and measures prior to having surgery. I had lost the abilities to walk, bend, sit, stand and enjoy any of life’s simple pleasures. Since my surgery, I feel 90% better than prior. The original pain I had prior to surgery is gone. Now I’m able to walk up the driveway. I can sit, stand, walk and most importantly play with my dog “Ginger.” I look forward to a brighter future.
Carol Turner, patient of Dr. Guy Danielson, Lindale, Texas
On August 18, 2005, I had back surgery. On September 1, 2005, I was prescribed the Orthofix Bone Growth Stimulator. Since surgery and use of bone growth stimulator, I am able to walk most of the time without a cane, and doctor has decreased my pain medication. Just to have these changes so far has been a blessing. Thank you!
Kathy L. Chapman, patient of Dr. Guy Danielson, Nacogdoches, Texas
Part Reference Numbers
| Part Reference No. | Description |
|---|---|
| 2505 | Cervical-Stim Bone Growth Stimulator |
Web Resources
- www.spineuniversity.com
- www.spine-health.com
- www.simmonssurgicalsociety.org
- www.spine.org
- www.csrs.org
Contraindications
There are no known contraindications for the Cervical-Stim as an adjunct to cervical spine fusion surgery.
Warnings
- The Cervical-Stim may interfere with the operation of a cardiac pacemaker or defibrillator. Consultation with the attending cardiologist is recommended
- The Cervical-Stim should be removed prior to any imaging procedures (e.g., CT scan, MRI, etc.)
Precautions
- The Cervical-Stim should not be used if there are mental or physical conditions that may preclude compliance with surgeon or device instructions
- The Cervical-Stim has not been evaluated in treating patients with the following conditions: osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone to vascular migraine headache, seizure, epilepsy, thyroid conditions or neurological diseases
- Animal teratological studies performed with this device did not show any adverse effects in animals. However, the safety of this device for use on patients who are pregnant or nursing has not been established
Footnotes
- Results from Orthofix Inc. PMA Randomized, Prospective Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion, 2004.
- Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with Clinical Outcome, Kevin Foley, M.D., Neurosurgery. Presented at the NASS 20th Annual Meeting, Philadelphia, PA
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