The Peregrine Study: A Safety and Performance Study of Renal Denervation

Inclusion Criteria: 1. Adult patient, age 18-75, male or female; 2. Patient has a clinic systolic blood pressure ≥ 160 mm Hg (or ≥ 150 mm Hg in type 2 diabetic patients) based on an average of 3 office/clinic measurements taken manually; 3. Patient has a daytime mean systolic pressure ≥135 mm Hg based on 24 hours ambulatory blood pressure monitoring, with \>85% valid readings. 4. Patient with resistant hypertension is receiving and adhering to a stable medication regimen of at least 3 anti-hypertensive medications of different classes (for at least 4 weeks), one of which must be a diuretic. The three (or more) - medication regimen must be maximal in terms of dose and tolerability in the judgement of the investigator, such that the next step in blood pressure management would be the addition of a further medication. 5. Patient has an eGFR ≥ 45 mL/min, based on the CKD-EPI equation; 6. Patient has no implanted ICD, pacemaker or neurostimulator or any metallic implant which is not compatible with magnetic resonance imaging. THis is applicable to sites were MRI is planned. Implanted devices are acceptable at sites where CT will be used 7. Patient has optimal renal artery anatomy (no clear abnormalities) based on Investigator's evaluation of CT-angiogram/ or as alternative MR-angiogram and /or renal angiogram including: * Single or two renal arteries, if each has a 5-7 mm diameter, respectively (accessory renal arteries are acceptable if diameter is is ≤ 2 mm, which will not be treated) * No aneurysms * No excessive tortuosity * No previous stenting or balloon angioplasty of the renal arteries * No previous renal denervation; 8. Patient has provided written informed consent Exclusion Criteria: 1. Patient has known or suspected secondary hypertension; 2. Patient has type 1 diabetes mellitus; 3. Patient requires chronic oxygen support; 4. Patient has primary or secondary pulmonary hypertension; 5. Patient has a known bleeding diathesis. 6. Patient has thrombocytopenia (platelet count \<100,000 platelets/µL; 7. Patient is pregnant or nursing or planning to become pregant; 8. Patient has significant imaging-assessed renovascular abnormalities including short length main renal artery (\< 10mm) and renal artery stenosis \>60% of the normal diameter segment; 9. Patient has history of nephrectomy, a single kidney, kidney tumor or urinary tract obstruction (with potential for hydronephrosis); 10. Patient is known to have a unilateral non-functioning kidney or unequal renal size (\>2 cm difference in renal length between kidneys); 11. Patient has a renal transplant; 12. Patient has a history of kidney stones; 13. Patient has a history of heterogeneities in the kidney such as cysts or tumors; 14. Patient has a history of pyelonephritis; 15. Patient has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months; 16. Patient has hemodynamically significant valvular heart disease; 17. Patient has heart failure (NYHA III or IV) or has an ejection fraction ≤ 30%; 18. Patient has a known allergy to contrast media; 19. Patient has a life expectancy of \<12 months; 20. Patient is currently enrolled in other potentially confounding research, i.e., another therapeutic or interventional research trial. Patients enrolled in observational registries may still be eligible.