ReCor Medical Paradise uRDN System Evaluated in Concurrently Published RADIANCE Studies

February 28, 2023—ReCor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., announced the publication of primary endpoint results from the RADIANCE II pivotal trial, which showed that the Paradise ultrasound renal denervation (uRDN) system successfully reduced blood pressure compared to a sham control. Also published were pooled analysis results from the combined primary efficacy endpoint and safety data from the RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II trials, showing a consistent blood pressure–lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension, stated the company.

The findings from RADIANCE II were published by Michel Azizi, MD, et al in JAMA: Journal of the American Medical Association (2023;329:651-661). The pooled analysis results were published online by Ajay Kirtane, MD, et al in JAMA Cardiology.

According to ReCor, RADIANCE II is a randomized, sham-controlled pivotal trial of the Paradise uRDN system in the treatment of patients with uncontrolled hypertension conducted under an FDA investigational device exemption.

The international multicenter study enrolled 224 patients with uncontrolled hypertension at > 60 study centers in eight countries. The patients 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.

The company reported that 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 and clinically relevant between-group difference of –6.3 mm Hg (P < .0001). The study also achieved its primary safety composite outcome with no major adverse events observed.

The RADIANCE pooled analysis concurrently published in JAMA Cardiology includes data from > 500 patients randomized in the three studies from ReCor’s RADIANCE Global Program. RADIANCE-HTN TRIO studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II studied patients with mild-moderate hypertension.

The combined data set showed an overall reduction in daytime ambulatory systolic blood pressure in the uRDN group of –8.5 mm Hg with a difference between treatment and sham at 2 months of –5.9 mm Hg (P < .0001), favoring uRDN. Blood pressure results were similarly positive in the 24-hour, nighttime, home, and office measures. A favorable safety profile was consistently observed after uRDN treatment across the studies, advised the company.

Dr. Kirtane and Professor Azizi are Principal Investigators of RADIANCE II. Dr. Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital in New York, New York. Prof. Azizi is Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, in Paris, France.

“The results of the RADIANCE clinical trials are meaningful in that they solidify the role of the Paradise uRDN system as an adjunctive therapy for hypertension treatment, in addition to medications and lifestyle modification,” commented Dr. Kirtane in the company’s press release. “Having three consistent sham-controlled clinical trials demonstrating that the Paradise uRDN system can safely lower blood pressure across a range of patients is a very high bar to have met.”

Prof. Azizi added, “The pooled analysis of RADIANCE SOLO, TRIO, and RADIANCE II shows a remarkable consistency of effect in patients with mild to moderate hypertension and those with resistant hypertension. These results are in line with the new 2023 consensus statement of the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The publication of these results in JAMA and JAMA Cardiology will bring the evidence of the performance of uRDN in the treatment of hypertension to a broad audience of physicians.”

The ESC-EAPCI clinical consensus statement on RDN for the management of hypertension in adults was recently published by Emanuele Barbato, MD, et al and is available online in both European Heart Journal and EuroIntervention.