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The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex.
NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The NeuroStar TMS Therapy® System is available upon the prescription of a licensed physician. It can be used in both inpatient and outpatient settings including physicians’ offices, clinics, and hospitals. “Prescription” means that the attending physician has determined that the NeuroStar TMS Therapy® System is indicated for use in a particular patient. In addition to patient selection, the attending physician should oversee initial patient motor threshold determinations, treatment parameter definitions, and overall TMS treatment course planning for each patient. “Supervision” means that the attending physician is medically responsible for coordination of the overall clinical care of a patient for whom NeuroStar TMS Therapy® has been considered clinically indicated and for the safe and effective use of the NeuroStar TMS Therapy® System. If the attending physician is not performing the daily NeuroStar treatment sessions, then the attending physician should assign properly trained personnel who may perform the daily treatment sessions. The attending physician is medically responsible for the patient’s routine evaluation during the course of their TMS therapy treatment.
NeuroStar TMS Therapy® System Prescribing Information:
The NeuroStar TMS Therapy® System is offered in the following configurations:
• Single mobile console configuration: mobile console, treatment coil, head support system, treatment chair, and TMS TrakStar practice data management system
• Multiple mobile consoles/TMS TrakStar system configurations to address the needs of facilities with large patient populations.
Since the NeuroStar TMS Therapy® System produces a time varying magnetic field, its intended effect derives fundamentally from Faraday’s Law, which asserts that a time-varying magnetic field produces an electrical current in an adjacent conductive substance. During TMS, the conductive substance of interest is the brain, in particular the region of the cortex that lies beneath the NeuroStar TMS Therapy® System treatment coil.
The electric current induced in this region of the cortex travels in a path orthogonal to the direction of the alternating magnetic field with the point of maximum field strength and greatest current located directly beneath the center of the coil, which is the NeuroStar TMS Therapy® System component that rests against the patient’s head and transmits magnetic pulses to the patient’s brain. The induced current is tangential to the scalp at the cortical surface, and diminishes in magnitude with increasing depth.
In the targeted area of the motor cortex, where field strength achieves the stimulation threshold, it is postulated that neuronal depolarization occurs. This type of magnetic field is not intended to induce a seizure during therapeutic use. The peak magnetic field strength achieved with each pulse in the cortex is approximately 0.5 Tesla.
Although the mechanism of action is unknown, it is hypothesized that the NeuroStar TMS Therapy® System causes neuronal depolarization and changes in brain functional activity that may be associated with various physiologic changes in the brain associated with symptomatic relief of depression in the indicated population.
Important Safety Information:
The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of NeuroStar TMS (<0.1% per patient). NeuroStar TMS Therapy® should not be used with patients who have non-removable conductive metal in or near the head. NeuroStar TMS Therapy® has not been studied in patients who have not received prior antidepressant treatment.
For Additional Safety Information:
NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.