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

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

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 ability to obtain an accurate blood pressure measurement

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

5. Individual has an estimated glomerular filtration rate (eGFR) of <30

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