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Orthofix

OrthoFix SpinalStim

The SpinalStim™ device is FDA approved to be used after spinal fusion surgery or to be used to treat a failed fusion from a previous surgery. The devices stimulate the natural healing process of bone by sending low-level pulses of electromagnetic energy to the injury or fusion site. The device has an overall clinical success rate of 92% in treating spinal fusion surgery patients. In addition, the SpinalStim device can be used for treatment of a failed spinal fusion, reducing the need for a revision surgery.

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OrthoFix SpinalStim

The SpinalStim device has been approved by the FDA to be worn after cervical spine fusion surgery in patients at risk for non-fusion.1,2 For complete prescribing information, please refer to the Instruction Manual.

This single-piece device is lightweight, flexible and portable, allowing freedom of movement during treatment. Typical prescribed treatment time is three hours per day. 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 onTrackmobile app is patient-friendly and provides patients with a treatment calendar, therapy reminders, and additional educational resources.*

​Why Do Physicians Prescribe a SpinalStim 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

Indications

The SpinalStim device is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

Contraindications

Cardiac pacemakers may be adversely affected by exposure to pulsed electromagnetic fields. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker.

 

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 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 a goal of avoiding a revision surgery.

 

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