OrthoFix Cervical Stim
Orthofix Spine Fusion Stimulators use a unique PEMF signal to create a conducive environment for spinal fusion. PEMF has been clinically proven to be a safe and effective noninvasive treatment to improve healing rates.
The CervicalStim™ device is the only bone growth stimulation therapy approved by the FDA as a noninvasive, adjunctive treatment option for cervical fusion in patients at high-risk for non-fusion. The device uses a pulsed electromagnetic field (PEMF) to induce a low-level electrical field at the fusion site which stimulates bone healing at a molecular, cellular, and tissue level. With an overall clinical success rate of 84 percent, the CervicalStim device increases fusion success significantly by 22 percent when used adjunctively to surgery.
The CervicalStim device has been approved by the FDA to be worn after cervical spine fusion surgery in patients at risk for non-fusion. For complete prescribing information, please refer to the Instruction Manual.
It is a single-piece device that is lightweight, flexible and portable, allowing freedom of movement during treatment. An LCD and audible alarm provide important feedback during treatment such as the operational status, treatment time remaining, battery capacity, etc.
Designed for patient ease of use
- Works effectively when worn over clothing or bracing
- Single-piece, cordless design allows for ease of placement and patient mobility
- The STIM onTrack™mobile app is patient-friendly and provides patients with a treatment calendar, therapy reminders, and additional educational resources.*
This device utilizes Orthofix PEMF technology that provides 360 degrees of treatment coverage around the fusion site, covering up to five vertebral levels.3
Why do physicians prescribe a CervicalStim device?
- High clinical success rates
- Statistically significant results for patients who smoke or have a multi-level fusion
- PEMF signal covers 360 degrees around the fusion site
- Coverage up to 5 vertebral levels
- Supported by the North American Spine Society’s coverage recommendations
- STIM on Track mobile app enables physicians to remotely view patient adherence to prescribed treatments
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HOW PEMF STIMULATES SPINE FUSION
How does PEMF affect spinal fusion? A successful spinal fusion depends on many complex healing processes. In patients with conditions and risk factors that can lower fusion success rates, pulsed electromagnetic field (PEMF) stimulation helps create an environment conducive to healing. PEMF stimulation is a safe, noninvasive treatment prescribed by a physician to promote spine fusion success, or to treat a failed lumbar fusion with the goal of avoiding a revision surgery.1-5 The Orthofix Cervical-Stim® and Orthofix Spinal-Stim® devices help promote spinal fusion by providing, 360 degrees of PEMF coverage that reaches up to five vertebral levels.
Research on the molecular impact of PEMF demonstrates:
• Exposure of a bone-forming cell (osteoblast) to PEMF generates an electric field gradient across the cell membrane
• Following this activation, bone cells recognize PEMF with an immediate intracellular response
• Similar to growth factors (PTH and Insulin), PEMF activates signaling pathways within minutes
• Activating these signaling pathways with PEMF (P13-mTor-p70-s6) results in cell growth, proliferation, and differentiation
Indications
The CervicalStim device is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk for non-fusion.
Contraindications
There are no known contraindications for the CervicalStim device as an adjunct to cervical spine fusion surgery.
