Continued Safety and Performance of the TIVUS System

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension

The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:

• TIVUS™ Severe Resistant HTN Cohort
• TIVUS™ Moderate Resistant HTN Cohort
• TIVUS™ Failed RF Therapy Cohort

Inclusion Criteria:

• Patient is ≥ 18 and ≤ 80 years of age
• For Cohort A: Documented office systolic blood pressure > 160 mmHg (> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure > 140 mmHg (> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure > 150 mmHg (> 140 mmHg for diabetic patients)
• Documented 24 hour systolic ABPM > 135 mmHg
• Adherence to a stable drug regimen
• For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening
• Suitable renal artery anatomy
• Male or non-pregnant / non-lactating female
• Patient understands the nature of the procedure and provides written informed consent
• Patient is willing and able to comply with the specified study requirements and follow-up evaluations

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)