Six-month “on-medication” results from the RADIANCE-HTN SOLO clinical trial have found that patients treated with the Paradise ultrasound denervation system (ReCor Medical Inc.) were prescribed fewer antihypertensive medications than those treated with a sham procedure, and accounting for this difference, treated patients had greater blood pressure drops than those in the sham arm. The findings were announced at the American College of Cardiology meeting (ACC 19) in New Orleans, USA (16–18 March) and simultaneously published in Circulation.
The RADIANCE-HTN SOLO study was of a cohort of patients who, following positive two-month “off-meds” blood pressure primary outcome, remained blinded to treatment assignment and were put back on medications on a recommended, pre-set, stepped care, medical titration protocol.
Co-principal Investigator Ajay Kirtane (Columbia University Irving Medical Centre, New York, USA) also noted that at six months the blood-pressure lowering effect of the Paradise system was maintained, and there were no major adverse events.
In a press release he said: “These results are unique in that they represent blinded randomised data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that, in addition to the previously presented SOLO results in patients who were ‘off’ medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with antihypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals–something that is frequently not achieved in clinical practice.”
The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the USA. It has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor says it will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension), REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea) and, most recently, with the launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the USA and Europe.
