The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Inclusion Criteria:

- Previously or currently prescribed antihypertensive therapy

- Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2
classes of antihypertensive medication

- Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in
period

Exclusion Criteria:

- Lacks appropriate renal artery anatomy for treatment

- Known, uncorrected causes of secondary hypertension other than sleep apnea

- Type I diabetes mellitus or uncontrolled Type II diabetes

- eGFR of <40

- Brachial circumference ≥ 42 cm

- Any history of cerebrovascular event or severe cardiovascular event, or history of
stable or unstable angina within 12 months prior to consent

- Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to
screening period, or any hospitalization for hypertensive crisis within 3 months prior
to screening period

- Chronic oxygen support or mechanical ventilation other than nocturnal respiratory
support for sleep apnea

- Primary pulmonary hypertension

- Night shift workers

- Pregnant, nursing or planning to become pregnant