ReCor Medical announced today that it completed enrollment in its Radiance-II pivotal trial of the Paradise ultrasound renal denervation (uRDN) system.
The Radiance-II trial of the Paradise uRDN system will evaluate the platform in the treatment of uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications.
ReCor Medical designed its Paradise platform as a device-based, minimally invasive procedure for treating high blood pressure. The procedure usually takes less than an hour, with the Paradise catheter placed in the renal artery.
Palo Alto, California-based ReCor Medical said in a news release that, subject to study outcomes, Radiance-II trial results will be combined with previously released data from the company’s Radiance-HTN Solo and Trio studies in a premarket application to the FDA for market approval in the U.S.
Radiance-II, a randomized, sham-controlled clinical trial, randomizes patients at a 2:1 ratio to Paradise uRDN or sham after four weeks of washout from antihypertensive medications. The primary efficacy endpoint is the difference in daytime ambulatory systolic blood pressure between Paradise uRDN and sham measured at two months post-procedure. The primary safety endpoint is a composite of 30-day major adverse events.
The company said that more than 1,000 study subjects have been enrolled over three years at more than 50 study centers in six countries, with over 200 patients randomized to uRDN or a sham procedure. ReCor’s Paradise uRDN holds CE mark for treating hypertension in Europe and is currently an investigational device in the U.S.
Michel Azizi, professor of medicine at Université Paris Cité, head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France, is a co-investigator for the trial. Ajay Kirtane, professor of medicine at Columbia University, Vagelos College of Physicians and Surgeons and New York-Presbyterian Hospital, is the other co-investigator.
“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,” Azizi and Kirtane said in the release. “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. We look forward to their continued help in the coming months to complete this landmark study, and we are excited to assess trial outcomes later this year.”