Otsuka Medical Devices’ subsidiary ReCor Medical has completed subject enrolment in the RADIANCE-II pivotal trial of its Paradise Ultrasound Renal Denervation (uRDN) System to treat hypertension.
The company has designed the Paradise uRDN System as a minimally invasive procedure for treating overactive nerves leading to the kidney.
The randomised, sham-controlled RADIANCE-II pivotal trial is designed for the evaluation of the platform to treat uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications.
Patients in the study are randomised at a 2:1 ratio to Paradise uRDN or sham after four weeks of washout from antihypertensive medications.
The difference in daytime ambulatory systolic blood pressure (BP) between Paradise uRDN and sham, which will be measured at two months after the procedure, will be the study’s primary efficacy endpoint.
The company noted that the trial’s primary safety endpoint is a composite of 30-day major adverse events.
Over three years, more than 1,000 participants have been enrolled at more than 50 study centres in six countries.
Université Paris Cité Medicine professor Michel Azizi and Columbia University Medicine professor Ajay Kirtane said: “The RADIANCE-II pivotal trial was carefully designed to assess the BP-lowering efficacy and safety of treating uncontrolled hypertension with the Paradise uRDN System.
“We are grateful to the investigators and study participants across the globe for their work on the study – especially through the challenges created by the Covid-19 pandemic over the past two years.”
Azizi and Kirtane are the co-principal investigators of the study.
The company stated that the RADIANCE-II trial is the third component of its RADIANCE Clinical Trial programme conducted in hypertension patients.
The results of the trial will be combined with the data from the RADIANCE-HTN SOLO and TRIO studies in a pre-market application to the US Food and Drug Administration (FDA) seeking market approval in the country.