First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension

Inclusion Criteria: * Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period * Mean daytime systolic ABPM ≥135 mmHg during screen-in period * Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure * No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment * Negative pregnancy test for women of child-bearing age * Willingness and able to comply with follow-up requirements * Signed informed consent Exclusion Criteria: * Secondary causes of hypertension * Calculated eGFR \<30mL/min/1.73m2 * History of repeated episodes of hypoglycemic unawareness * Morbid obesity, defined as Body Mass Index \>40 kg/m2 * Severe obstructive sleep apnea (AHI \> 35/hr.) * Pacemaker and/or implantable defibrillators * History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening * History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening * History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting