Orthofix, Inc., a Texas based company, has received the Frost & Sullivan’s 2005 Product Leadership of the Year Award in the field of spinal stimulation treatment. “The award is presented recognizing the company’s efforts to develop a fist-ever FDA approved bone growth stimulator, Cervical-Stim®,” reported Frost & Sullivan.
From the product FAQ page:
What is Cervical Stim?
Cervical-Stim® is a new, non-invasive, pulsed electromagnetic bone growth stimulator indicated for adjunctive use to increase the frequency of cervical fusion success by six months in high-risk (i.e., multilevel fusion, smoking, allograft) patients.
Is this the same device that was used off-label?
Cervical Stim is a brand new, FDA-approved device and has never been used off-label.
Which patients are considered high-risk?
The Cervical Stim was clinically studied in high-risk subjects who had undergone cervical fusion with allograft for degenerative conditions and were smokers (one pack per day or more), multilevel fusion or both. Other conditions that may put a patient at high risk for a failed fusion are diabetes, obesity, osteoporosis, chronic oral steroid use, and any metabolic bone disease. A high-risk patient may have difficulty with bone healing due to any of these risk factors.
How does Cervical Stim work?
Cervical Stim Cervical Fusion System is an external, low-level PEMF (Pulsed ElectroMagnetic Field) treatment device which helps activate and augment the body’s natural bone healing process after fusion surgery.
The device contains a microprocessor (computer chip) that generates the therapeutic treatment signal. The Cervical Stim is battery-powered and has an integrated control unit and treatment transducer combined in a single piece device, which allows the patient ambulatory treatment. The system is placed on the neck and may be worn with or without a brace.
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