SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Inclusion Criteria:

   - Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a
   diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.

   - Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140
   mmHg and < 170 mmHg.

   - Individual is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

   - Individual lacks appropriate renal artery anatomy.

   - Individual has estimated glomerular filtration rate (eGFR) of <45.

   - Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.

   - Individual has one or more episodes of orthostatic hypotension.

   - Individual requires chronic oxygen support or mechanical ventilation other than
   nocturnal respiratory support for sleep apnea.

   - Individual has primary pulmonary hypertension.

   - Individual is pregnant, nursing or planning to become pregnant.

   - Individual has frequent intermittent or chronic pain that results in treatment with
   nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the
   month prior to enrollment.

   - Individual has stable or unstable angina within 3 months of enrollment, myocardial
   infarction within 3 months of enrollment; heart failure, cerebrovascular accident or
   transient ischemic attack, or atrial fibrillation at any time.

   - Individual works night shifts.