Nexstim NBS 6 Depression Therapy Brochure


 
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Intended purpose & Indications for use:

Major Depressive Disorder (CE mark, FDA clearance, for information on other regional clearances contact Nexstim):

Intended purpose: NBS 6 is intended to be used for treatment of major depressive disorder (MDD) by targeting and delivering noninvasive repetitive TMS stimulation to the patient's dorsolateral prefrontal cortex.

Indications for use: NBS 6 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. NBS 6 is intended to be use by trained clinical professionals.

Chronic Neuropathic Pain (CE mark, for information on other regional clearances contact Nexstim):

Intended purpose: In adult patients suffering from chronic unilateral neuropathic pain, NBS 6 is intended to provide electric field navigated noninvasive repetitive TMS stimulation as therapy to alleviate pain. NBS 6 is intended to be used by trained clinical professionals.

Indications for use: NBS 6 is indicated for MRI-guided and electric field (or E-field) navigated, noninvasive repetitive TMS stimulation (rTMS) of the motor cortex as therapy to alleviate chronic unilateral neuropathic pain in adult patients. Nexstim NBS 6 is intended to be used by trained clinical professionals.

Nexstim NBS 6 is not cleared by the FDA for commercial use of the treatment of chronic pain in the United States, for investigational use only

Pre-procedural mapping (CE mark, FDA clearance, for information on other regional clearances contact Nexstim):

Intended purpose: NBS 6 is intended to be used for localization and assessment of the motor cortex and motor tract integrity for pre-procedural planning purposes. NBS 6 is intended to be used for localization and assessment of cortical areas of speech function for pre-procedural planning purposes.

Indications for use: NBS 6 is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. NBS 6 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. NBS 6 is indicated for noninvasive localizations of cortical areas that do not contain essential speech function. NBS 6 provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NBS 6 is intended to be verified by direct cortical stimulation. NBS 6 is not intended to be used during a surgical procedure. NBS 6 is intended to be used by trained clinical professionals.

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