ReCor Medical and its parent company, Otsuka Medical Devices, recently announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). 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 randomised, sham-controlled US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial of the Paradise uRDN system in the treatment of patients with uncontrolled hypertension. Conducted as an international multicentre study at more than 60 study centres in eight countries, 224 patients with uncontrolled hypertension were randomised 2:1 to uRDN or a sham.
Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified blood pressure 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 -6.3mmHg (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 randomised in the three studies from ReCor’s RADIANCE global programme: 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 blood pressure in the uRDN group of -8.5mmHg with a difference between treatment and sham at two months of -5.9mmHg (p<0.0001), favouring uRDN. Blood pressure results were similarly positive in the 24-hour, night-time, home, and office measures. A favourable 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 co-principal investigator Ajay Kirtane (New York-Presbyterian Hospital, New York, USA).
Co-principal investigator Michel Azizi (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.”
“With hypertension being a leading cause of cardiovascular disease worldwide, it is vital that we help patients with an effective therapy to reduce blood pressure. We are pleased that the RADIANCE clinical trials have repeatedly shown that the Paradise uRDN system can successfully reduce blood pressure in a broad range of patients,” said ReCor president and CEO, Lara Barghout. “ReCor is focused on bringing the Paradise uRDN system to patients and their physicians as a treatment option in the near future.”