SpinalStim™ Device

SpinalStim™ Device

Description

Spinal-Stim delivers the highest success rates in bone growth stimulation for spine fusion and pseudarthrosis salvage. In fact, 92% of patients using Spinal-Stim adjunctively achieved fusion success.

Features & Benefits

This single-piece device is lightweight, flexible and portable, allowing freedom of movement during treatment. The typical prescribed treatment time is two 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
  • Cordless design enables you to keep moving while healing
  • A patient friendly mobile app, STIM onTrack™, with patient usage data*
  • Daily treatment reminder via the STIM onTrack™ mobile app*

This device utilizes Orthofix PEMF technology that provides 360 degrees of treatment coverage around the fusion site.14 The SpinalStim device has an overall success rate of 92% in treating spinal fusion surgery patients.5, 11, 12 In addition, the SpinalStim device can be used for treatment of a failed spinal fusion, reducing the need for a revision surgery.5,11

Why do physicians prescribe a SpinalStim device?

  • High clinical success rates5, 11, 12
  • Statistically significant results for patients who smoke or have a multi-level fusion5, 11, 12
  • PEMF signal covers 360 degrees around the fusion site14
  • Coverage up to 5 vertebral levels14
  • Supported by the North American Spine Society’s coverage recommendations20

Part Number

Description

5212SpinalStim™ device

The SpinalStim Device

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.

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. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.

Full prescribing information can be found in product labeling or
by calling Patient Services at 1-800-535-4492.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

SpinalStim™ device instruction manual