Principal Investigator
Conducted as an international, multicenter study, RADIANCE II is a US FDA IDE, randomized, sham-controlled pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Among 1038 patients screened for eligibility at more than 60 study centers in 8 countries, 224 patients with uncontrolled hypertension were randomized 2:1 to uRDN or a sham. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified BP criteria were exceeded. At the 2-month primary efficacy endpoint, patients treated with the Paradise uRDN system had a mean reduction in daytime ambulatory systolic blood pressure of -7.9 mmHg, compared to a reduction of -1.8 mmHg in the sham arm, corresponding to a statistically significant between-group difference of -6.3 mmHg (p
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