Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Exclusion Criteria

• •1. Currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• •2. A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject.
• •3. A planned procedure that is contraindicated for VNS therapy.
• •4. History of implantation of the VNS Therapy System.
• •5. Currently receiving treatment from an active implantable medical device.
• •6. Presence of contraindications to MRI per the MRI subject screening record.
• •7. Known clinically meaningful cardiovascular arrhythmias currently being managed by devices or treatments that interfere with normal intrinsic heart rate responses (e.g., pacemaker dependency, implantable defibrillator, beta adrenergic blocker medications).
• •8. History of chronotropic incompetence (commonly seen in subjects with sustained bradycardia \[heart rate \< 50 bpm\]).
• •9. Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments.
• •10. History of status epilepticus within 1 year of study enrollment.
• •11. Dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years, based on history. Tests for drug or alcohol use will not be administered.
• •12. Currently being treated with prescribed medication that contains cannabis or cannabis related substance including recreational use.
• •13. Any history of psychogenic non-epileptic seizures.
• •14. Currently participating in another clinical study without LivaNova written approval.