Continued Safety and Performance of the TIVUS System

Exclusion Criteria

• •eGFR \< 45mL/min/1.73m2
• •Documented primary pulmonary hypertension
• •Patient experienced \>1 episode of orthostatic hypotension coupled with syncope
• •Documented indicator of a secondary renal hypertension
• •History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months
• •Planned major surgery or cardiovascular intervention in the next 6 months
• •Surgery or cardiovascular intervention in the previous 3 months
• •Hemodynamically significant valvular heart disease
• •Severe debilitating lung disease
• •Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
• •Patient has a single functioning kidney
• •Documented thrombocytopenia, clotting disorders or aortic aneurysms
• •Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
• •Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
• •Concurrent enrollment in another trial
• •Main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length
• •Aorto-renal angle that prevents a safe cannulation of the renal artery
• •Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
• •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
• •Any renal artery stenosis \> 50% by visual assessment
• •Any renal artery aneurysm in either renal artery
• •A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)