Otsuka Medical Devices Co., Ltd. ('Otsuka Medical Devices') a wholly owned subsidiary of Otsuka Holdings announced the detailed results from the RADIANCE II US FDA IDE pivotal trial evaluating the endovascular Paradise Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension.

Principal Investigator Ajay J. Kirtane, MD, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital, presented the study results in a Late Breaking Clinical Science session at the TCT 2022 Annual Meeting. The highly anticipated results follow ReCor's announcement in July that the RADIANCE II study met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure at two months between uRDN and a sham procedure.

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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