Rheos® Pivotal Trial

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.