Traitement par fusion vertébrale 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.^1-3 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.^1-3 In addition, the SpinalStim device can be used for treatment of a failed spinal fusion, reducing the need for a revision surgery.^1,2

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 onTrack^™mobile 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^1-3
Statistically significant results for patients who smoke or have a multi-level fusion^1-3
PEMF signal covers 360 degrees around the fusion site⁴
Coverage up to 5 vertebral levels⁴
Supported by the North American Spine Society’s coverage recommendations⁴
STIM on Track mobile app enables physicians to remotely view patient adherence to prescribed treatments

*STIM onTrack mobile app is available as an accessory of US model devices only

Sites web d’informations pour les patients

http://bonegrowththerapy.com/

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.

Contre-indications

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.

See Patient Manual for additional product labeling information.

Documentation connexe

Footnotes

*The results of preclinical studies may not be indicative of human clinical trials.

PMA P850007/S6. février 1990.
Simmons JW, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics, 2004 Jan;33(1):27-30.
Zborowski M, Androjna C, Waldorff El, Midura RJ 2015 Comparison or therapeutic magnetic stimulation with electric stimulation of spinal column vertebrae. IEEE Transactions on Magnetics 51(12): #5001009, doi: 10.1109/TMAG.2015.2458297
spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx

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