RADIANCE II Pivotal Trial Results Presented for ReCor Medical's Paradise Ultrasound RDN System

September 18, 2022—ReCor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced the detailed results from RADIANCE II trial of the company's endovascular Paradise ultrasound renal denervation (uRDN) system as a treatment for patients with uncontrolled hypertension. The international, multicenter study is a randomized, sham-controlled pivotal trial conducted under an investigational device exemption from the FDA.

The presentation comes after the company announced on July 26 that the RADIANCE II study met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure at 2 months between uRDN and a sham procedure.

The study’s Principal Investigators are Ajay Kirtane, MD, and Professor Michel Azizi, MD. Dr. Kirtane is Professor of Medicine at Columbia University’s Vagelos College of Physicians and Surgeons/NewYork-Presbyterian Hospital in New York, New York. Dr. Azizi is Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, in Paris, France.

Dr. Kirtane presented the study results in a Late Breaking Clinical Science session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

As summarized by ReCor Medical, the trial screened 1,038 patients for eligibility at more than 60 study centers in eight countries. Of these, 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 blood pressure 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 mm Hg, compared to a reduction of -1.8 mm Hg in the sham arm, corresponding to a statistically significant between-group difference of -6.3 mm Hg (P < .0001). Similar reductions in blood pressure were observed in nighttime and 24-hour measures, as well as measurements taken at home and in the physician office. No major adverse events were seen at 30 days.

The company advised that the primary safety endpoint will be measured at 6 months, and patients will be followed for 60 months.

"These results are important to the field of hypertension treatment," commented Dr. Kirtane in ReCor Medical's press release. "RADIANCE II is the third and largest randomized, sham-controlled study to show that the Paradise uRDN system delivers meaningful reductions in blood pressure in patients with uncontrolled hypertension."

Dr. Kirtane continued, "On behalf of my coprincipal investigator Professor Michel Azizi and the entire steering committee, I would like to thank the study patients, investigators, and coordinators who gave so much of themselves—including during the COVID pandemic—in order to complete this rigorously conducted trial."

Prof. Azizi stated in the company' press release, "The results from RADIANCE II provide further evidence for uRDN as a potential therapy option for hypertension. The RADIANCE II results are strongly consistent across all measures of blood pressure within the study and are also consistent with the prior SOLO (off-medication) and TRIO (on triple antihypertensive combination treatment) trials—adding confidence in the treatment effect of the Paradise uRDN system across a broad spectrum of hypertension severity."

Prof. Azizi further noted, "These results align well with the recent consensus statement from the European Society of Cardiology, supporting the use of renal denervation for treatment of uncontrolled hypertension. Additionally, if these results are maintained over the long-term—as already shown by the 36-month results of the SOLO trial and 24-month results of the TRIO trial—the reductions in blood pressure seen in the RADIANCE trials are of a magnitude previously shown in hypertension drug trials to be associated with cardiovascular risk reduction."