SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

Inclusion Criteria:

1. Individual is diagnosed with hypertension and has a baseline office systolic bloodpressure ≥140 mmHg

2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg

3. Individual has an average systolic baseline home blood pressure ≥135 mmHg

Exclusion Criteria:

1. Individual lacks appropriate renal artery anatomy

2. Individual has undergone prior renal denervation

3. Individual has a documented condition that would prohibit or interfere with abilityto obtain an accurate blood pressure measurement

4. Individual requires chronic oxygen support or mechanical ventilation other thannocturnal respiratory support for sleep apnea

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

6. Individual has one or more episode(s) of orthostatic hypotension

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

8. Individual has primary pulmonary hypertension

9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2diabetes mellitus with glycosylated hemoglobin greater than 8.0%