What is degenerative disc disease?
With degenerative disc disease, the intervertebral discs can become worn and thin and the space between the vertebrae becomes shorter. As the space is compressed, the vertebrae impinge upon the nerves resulting in significant pain. Pieces of damaged disc may also break off and cause irritation of the nerves. As the disc loses its ability to absorb stress and provide support, other parts of the spine become overloaded, leading to irritation, inflammation, fatigue and muscle spasms.
What patient population undergoes cervical fusion surgery?
Cervical spine fusion is often performed for patients with degenerative disc disease or after an injury or trauma. For degenerative disc disease, cervical fusion is performed using graft material in order to relieve the pressure on the compressed nerve. After trauma or injury, fusion is performed in order to stabilize the neck and prevent a bone fracture from causing instability or damage to the spinal cord, and possibly, paralysis. Cervical spine fusion is also performed to treat conditions such as misalignment of the vertebrae, as a treatment for spinal stenosis (narrowing), a herniated disc, effects of rheumatoid arthritis, infection, tumors, or spinal deformities (Source: WebMD).
What is Cervical-Stim?
Cervical-Stim is a new, noninvasive, 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.
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 Pulsed ElectroMagnetic Field (PEMF) 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.
What is PEMF and how does it work?
PEMF stands for Pulsed ElectroMagnetic Field and is a low-energy, time-varying magnetic field that has been proven effective in promoting bony arthrodeses in fracture nonunions. Application of PEMF activates the body's natural repair mechanism when it is absent or not fully functional in certain patients, and enhances bone growth for successful fusion outcomes.
The technology and design utilized is the same as that of Orthofix's other FDA-approved bone growth stimulators currently marketed by Orthofix International, N.V.
The clinical success of PEMF bone growth stimulation has been clinically proven and used successfully on more than 200,000 spine patients since 1990.