ReCor Medical announced that a trial for its Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint.
Palo Alto, California-based ReCor’s RADIANCE II pivotal trial evaluated Paradise as a treatment for hypertension. The trial operated under FDA investigational device exemption. ReCor presented results at TCT 2022 in Boston. They follow the company’s July announcement that Paradise met its primary endpoints in the same trial.
ReCor Medical is part of Otsuka Holdings’ Otsuka Medical Devices subsidiary.
The randomized, sham-controlled pivotal trial evaluated 224 patients with uncontrolled hypertension. The trial randomized patients 2:1 for uRDN or sham. Patients had to remain off antihypertensive medications throughout the 2 months of follow-up — unless they exceeded specified BP criteria.
At two months, patients treated with the Paradise uRDN system had a mean reduction in daytime ambulatory systolic blood pressure of -7.9 mm Hg. In comparison, there was a reduction of -1.8 mm Hg in the sham arm. That represents a statistically significant between-group difference of -6.3 mm Hg.
The study also demonstrated similar reductions in blood pressure in nighttime and 24-hour measures. ReCor reported no adverse events at 30 days. The trial will measure the primary safety endpoint at six months with patients followed for 60 months.
ReCor’s ‘important’ results
“These results are important to the field of hypertension treatment. RADIANCE II is the third and largest randomized, sham-controlled study to show that the Paradise uRDN System delivers meaningful reductions in blood pressure in patients with uncontrolled hypertension,” said study principal investigator Ajay Kirtane. “On behalf of my co-principal investigator professor Michel Azizi and the entire steering committee, I would like to thank the study patients, investigators, and coordinators who gave so much of themselves—including during the COVID pandemic—in order to complete this rigorously conducted trial.”
Azizi noted that the results “align well” with a statement from the European Society of Cardiology, supporting the use of renal denervation for treatment of uncontrolled hypertension. He also said that, if the results sustain, the blood pressure reductions seen represent a magnitude previously shown in hypertension drug trials to be associated with cardiovascular risk reduction.”
“We are thrilled with the results from RADIANCE II. This is further evidence that the Paradise uRDN System lowers blood pressure in a wide range of patients who are struggling to control their hypertension,” said ReCor president and CEO, Andrew M. Weiss. “ReCor looks forward to working with physicians and regulating bodies around the world to make the Paradise system treatment available to patients and their physicians who are seeking better control of their hypertension.”
