Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

Exclusion Criteria

• •1. Subject has any secondary cause of hypertension
• •2. Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
• •3. Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
• •4. Subject has a history of intra-abdominal surgery within the past six months
• •5. Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
• •6. Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
• •7. MI, unstable angina, or CVA in the prior 6 months.
• •8. Known severe primary pulmonary HTN
• •9. Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
• •10. Subject has hemodynamically significant valvular heart disease.
• •11. Subject has BMI over 40 km/m\^2
• •12. Subject has a target treatment depth over 13 cm.
• •13. Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
• •14. Subject is pregnant, nursing, or intends to become pregnant during the trial period.
• •15. Subject is currently enrolled in other potentially confounding research.
• •16. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
• •17. Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule