The Global Paradise® System US Post Approval Study (US GPS)
The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
• Signed and dated study informed consent
• Documented history of hypertension
• Documented history of prior or current antihypertensive medication(s)
• Mean seated office systolic BP at screening ≥ 140 mmHg
• Mean pre-procedure home systolic BP of ≥ 135 mmHg
• Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2
⁃ RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.