EMBRACE Tremor BiFUS

Exclusion Criteria17

• Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
• Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
• Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.
• Patients with concurrent active infections disease and/or severe allergies with fever.
• Patients that have been diagnosed with brain tumors or a vascular anomaly.
• Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.
• Patients under anticoagulants and/or anti-platelets drugs known to increase bleeding risk within the duration defined by the half-life of the specific drugs.
• Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment
• Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \> 100 on medication).
• Patients with unstable cardiac status.
• Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.
• Cerebrovascular disease (multiple CVA or CVA within 6 months).
• Patients with risk factors for intraoperative or postoperative bleeding.
• Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.).
• Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia.
• Patient with cognitive impairment.
• Patient with clinically significant abnormal speech function as determined by a speech pathologist.