THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension

The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in: 1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure. 2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure

Inclusion Criteria: 1. Appropriately signed and dated informed consent 2. Male and female adults with age between ≥22 and ≤75 years at time of consent 3. Documented history of hypertension 4. Previously or currently prescribed antihypertensive therapy 5. Subject has an office BP (average of 3 seated measurements) of: 1. Uncontrolled BP: ≥ 140/90 mmHg \