Intended Use

Neuravive uses FDA approved focused ultrasound technology, Exablate Neuro, which is intended for use in patients with essential tremor whose tremors cannot be treated using medication. Patients must be at least 22 years old.

Safety

Exablate Neuro is contraindicated for patients who cannot have MR imaging, including those who have a non-MRI compatible implanted metallic device, such as a cardiac pacemaker, those with allergies to MR contrast agents or those with body size limitations for MR. Also, the treatment should not be used in patients who are pregnant, have advance kidney disease or on dialysis, those with unstable heart conditions or severe hypertension, patients exhibiting any behavior consistent with ethanol or substance abuse or patients with a history of abnormal bleeding, hemorrhage and/or blood clotting disorders (coagulopathy). Patients currently taking anticoagulant drugs or drugs known to increase the risk of hemorrhage, patients with a history of cerebrovascular disease (strokes) or brain tumors and patients who are not able to tolerate the prolonged stationary position also should not have the procedure.

Risks

Adverse events are consistent with those reported for thalamotomy surgery, including numbness/tingling of the fingers, imbalance/unsteadiness, ataxia (loss of control of body movements), or gait disturbance; also, some have experienced headache, dizziness, and/or nausea.