March 19, 2019
Six-Month "On-Medication" Results Presented From RADIANCE-HTN SOLO Trial
March 17, 2019—ReCor Medical, Inc. announced the 6-month "on-medication" results from the RADIANCE-HTN SOLO clinical trial of the company's Paradise renal denervation system for the treatment of uncontrolled hypertension. Results were presented by Coprincipal Investigator Ajay Kirtane, MD, at the American College of Cardiology's 68th Annual Scientific Session, held March 16–18 in New Orleans, Louisiana. The data were simultaneously published online by Michel Azizi, MD, et al in Circulation.
ReCor also announced the first randomization of patients in its RADIANCE-II pivotal trial of the Paradise system.
According to the company, the 6-month "on-medication" results from the RADIANCE-HTN SOLO study cohort come after the positive 2-month "off-medication" blood pressure primary outcome. In the 6-month results, patients remained blinded to treatment assignment and were put back on medications following a recommended, preset, stepped-care, medical titration protocol.
The results found that patients treated with the Paradise ultrasound denervation system 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, advised the company. Additionally, Dr. Kirtane noted that at 6 months, the blood pressure–lowering effect of the Paradise system was maintained and that there were no major adverse events.
Dr. Kirtane commented in the company's announcement, "Professor Michel Azizi, my Coprincipal Investigator for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee, and I are very pleased to report the 6-month 'on-meds' results from the SOLO cohort of the study. These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure."
Dr. Kirtane continued, "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."