ReCor Medical’s RADIANCE-II Pivotal Trial of Paradise uRDN System Completes Enrollment

March 29, 2022—ReCor Medical, Inc., a fully owned subsidiary of Otsuka Medical Devices Co., Ltd., announced completion of enrollment in the RADIANCE-II pivotal trial of the Paradise ultrasound renal denervation (uRDN) system. The Paradise uRDN system has received European CE Mark approval for the treatment of hypertension. It is an investigational device in the United States.

According to the company, RADIANCE-II is a randomized, sham-controlled clinical trial of the Paradise uRDN device for the treatment of uncontrolled hypertension in patients on zero to two antihypertensive oral medications. After 4 weeks of washout from antihypertensive medications, patients are randomized at a 2:1 ratio to either Paradise uRDN or a sham procedure.

The primary efficacy endpoint is the difference in daytime ambulatory systolic blood pressure between Paradise uRDN and sham measured at 2 months postprocedure. The primary safety endpoint is a composite of 30-day major adverse events.

More than 1,000 patients have been enrolled over 3 years at more than 50 study centers in six countries, with more than 200 patients randomized to uRDN or a sham procedure, noted ReCor Medical.

The study’s Coprincipal Investigators, Michel Azizi, MD, and Ajay Kirtane, MD, commented in ReCor Medical’s press release, “The RADIANCE-II pivotal trial was carefully designed to assess the blood pressure–lowering efficacy and safety of treating uncontrolled hypertension with the Paradise uRDN system. We are grateful to the investigators and study participants across the globe for their work on the study—especially through the challenges created by the COVID-19 pandemic over the past 2 years. We look forward to their continued help in the coming months to complete this landmark study, and we are excited to assess trial outcomes later this year.”

Dr. Azizi is Professor of Medicine at Université Paris Cité and Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou in Paris, France. Dr. Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork–Presbyterian Hospital in New York, New York.

The company advised that, subject to study outcomes, the RADIANCE-II results will be combined with the previously released data from the company’s RADIANCE-HTN SOLO and TRIO studies in a premarket application to the FDA for United States market approval. The findings will be presented to the scientific and medical communities in publications and conferences later this year.

Additionally, ReCor has begun the fourth component of the RADIANCE program with the launch of the Global Paradise System (GPS) registry. The GPS registry is a real-world study of patients with uncontrolled hypertension initiated in Germany earlier this year.