ReCor Medical announces two concurrent JAMA Network publications of study results on the Paradise ultrasound renal denervation system for the treatment of hypertension.

Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham.

In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Results of the pooled analysis showed a consistent blood pressure lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension.

RADIANCE II is a randomized, sham-controlled US FDA IDE pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Conducted as an international multicenter study at more than 60 study centers in eight countries, 224 patients with uncontrolled hypertension were randomized 2:1 to uRDN or a sham. Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified BP criteria were exceeded. At the two-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 and clinically relevant between-group difference of -6.3 mmHg (p<0.0001). the study also achieved its primary safety composite outcome with no major adverse events observed.

Concurrently published in JAMA Cardiology, the RADIANCE Pooled Analysis includes data from more than 500 patients randomized in the three studies from ReCor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. The combined dataset showed an overall reduction in daytime ambulatory systolic BP in the uRDN group of -8.5 mmHg with a difference between treatment and sham at two months of -5.9 mmHg (p<0.0001), favoring urdn. blood pressure results were similarly positive in the 24-hour, nighttime, home, and office measures. a favorable safety profile was consistently observed following urdn treatment across the studies.

“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. 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,” said study principal investigator Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.

Study principal investigator Michel Azizi, Professor of Medicine at Université?Paris Cité,?Hôpital Européen Georges Pompidou, Paris, France, 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.”

See-February 28, 2023- "Endovascular Ultrasound Renal Denervation to Treat Hypertension- The RADIANCE II Randomized Clinical Trial":Michel Azizi, MD, PhD; Manish Saxena, MBBS, MSc; Yale Wang, MD; et alfor the RADIANCE II Investigators and Collaborators JAMA. 2023;329(8):651-661. doi:10.1001/jama.2023.0713.

"Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials"- Ajay J. Kirtane, MD, SM; Andrew S. P. Sharp, MD; Felix Mahfoud, MD, MA4,; et al.; for the RADIANCE Investigators and Collaborators. JAMA Cardiol. Published online February 28, 2023. doi:10.1001/jamacardio.2023.0338.