CVRx Barostim Hypertension Pivotal Trial

Inclusion Criteria Highlights:

- Age at least 21 years and no more than 80 years at the time of randomization.

- On four or more maximally tolerated anti-hypertensive medications, one of which is a
diuretic. The antihypertensive medication regimen must remain unchanged for 4 weeks
prior to screening and must be expected to remain unchanged for at least 6 months
during follow-up.

- Protocol defined systolic blood pressure greater than or equal to 160 mmHg.

- Protocol defined 24-hour Ambulatory Blood Pressure Monitoring (ABPM) greater than or
equal to 135 mmHg.

- Serum estimated glomerular filtration rate (eGFR) > 29 mL/min/1.73 m^2.

- Appropriate surgical candidate.

- Women of childbearing potential must use a medically accepted method of birth control
and agree to continue use of this method for the duration of the study. Women of
childbearing potential must have a negative pregnancy test within 14 days prior to
randomization.

Exclusion Criteria Highlights:

- Known or suspected baroreflex failure or autonomic neuropathy.

- Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension,
unstable angina, syncope, or cerebral vascular accident within the 3 months.

- Hypertension secondary to an identifiable and treatable cause other than sleep apnea.

- Prior surgery, radiation, or endovascular stent placement in the carotid sinus
region.