Data from RADIANCE-HTN SOLO trial of Paradise Renal Denervation System for hypertension results
ReCor Medical announced the 6 month "on-medication" results from its RADIANCE-HTN SOLO clinical trial with simultaneous publication in Circulation, and the first randomization of patients in its RADIANCE-II pivotal trial of its Paradise Renal Denervation System for the treatment of uncontrolled hypertension. The 6 Month "on-meds" results from the RADIANCE-HTN SOLO study cohort where presented in which, following the positive 2-month "off-meds" blood pressure primary outcome, patients remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol.
The results demonstrated that patients treated with the ReCor Paradise Ultrasound Denervation System were prescribed fewer anti-hypertensive 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. In addition at 6 months the blood-pressure lowering effect of the Paradise System was maintained and that there were no major adverse events.
See: "Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial" Michel Azizi et al. Circulation 17 Mar 2019 https://doi.org/10.1161/CIRCULATIONAHA.119.040451