Global Paradise System US Post Approval Study

Inclusion Criteria:

• Signed and dated study informed consent

• Documented history of hypertension

• Documented history of prior or current antihypertensive medication(s)

• Mean seated office systolic BP at screening ≥ 140 mmHg

• Mean pre-procedure home systolic BP of ≥ 135 mmHg

• Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2

RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.

Exclusion Criteria:

Patients who meet the following will be excluded from participation:

• Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter

• Patient under the age of 18 years old at the time of consent

• Patient is pregnant

• Patients with transplanted kidney

• Presence of abnormal kidney (or secreting adrenal) tumors

To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:

• Renal arteries with diameter < 3mm and > 8mm

• Renal artery with fibromuscular dysplasia (FMD)

• Stented renal artery

• Renal artery aneurysm

• Renal artery diameter stenosis >30%

• Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter