Inclusion Criteria:

• Be at least 21 years of age and no more than 80 years of age.
• Have been assessed with bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible.
• Office cuff systolic blood pressure greater than or equal to 160 mmHg and have a diastolic blood pressure greater than or equal to 80 mmHg as well as a 24-hour ambulatory systolic blood pressure greater than or equal to 135 mmHg despite at lest one month of maximally tolerated therapy with at least three anti-hypertensive medications, of which at least one must be a diuretic.
• Must have completed the drug compliance questionnaire and have been judged to be compliant with medications.
• For subjects that have had prior bariatric surgery, they must be at least 1 year post-surgery and at a stable weight.
• If female, the subject must be surgically sterile, or using a medically accepted method of birth control and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative serum pregnancy test in the pre-implant blood evaluation.
• Must be an appropriate or reasonable surgical candidate.
• Have signed a CVRx approved informed consent form for participation in this study

Exclusion Criteria:

• Have known or suspected baroreflex failure or autonomic neuropathy.
• Have an arm circumference greater than 46 cm and/or body mass index of greater than 45.
• Have significant cardiac bradyarrhythmias.
• Have chronic atrial fibrillation.
• Have significant orthostatic hypotension
• Had a solid organ or hematologic transplant.
• Had a myocardial infarction, unstable angina, syncope, or cerebral vascular accident within the past 3 months.
• Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within 6 months of enrollment in the trial.
• Have ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
• Have prior surgery, radiation, or endovascular stent placement in either carotid sinus region.

• Have severe chronic kidney disease as defined by:

  • Currently undergoing dialysis or dialysis is planned within 3 months of the implant date
  • eGFR of ≤30 ml/min/1.73m²
• Have hypertension secondary to an identifiable and treatable cause other than sleep apnea.
• Have clinically significant cardiac structural valvular disease.
• Have clinically significant reactive airway disease, chronic obstructive pulmonary disease, and/or primary pulmonary hypertension.
• Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
• Have a clinically significant psychological illness that would prohibit the subject's ability to meet the protocol requirements
• Are currently taking an imidazolone receptor agonist
• Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
• Have an active infection within the last month.
• Have a co-morbid condition that reduces life expectancy to less than one year.
• Are enrolled in another concurrent clinical trial, without prior approval of CVRx.