The RADIANCE CED Study

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study

The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.

Common Inclusion Criteria:

• Adults aged ≥65 years with uncontrolled hypertension
• Stable regimen of blood pressure-lowering medication

Common Exclusion Criteria:

• Hypertension due to secondary causes
• Prior renal denervation treatment
• Pregnancy
• End-stage renal disease, dialysis, or kidney transplant