Patients using the Paradise uRDN system had a decrease in daytime ambulatory systolic blood pressure, which averaged -7.9mmHg, in comparison to a reduction of -1.8mmHg in the sham arm
Otsuka Medical Devices has unveiled the findings of the sRADIANCE II US FDA IDE pivotal trial. (Credit: Antonio Corigliano from Pixabay)
Otsuka Medical Devices said that its Paradise ultrasound renal denervation system (uRDN) delivered a significant reduction in the blood pressures (BPs) of patients with uncontrolled hypertension in the RADIANCE II trial.
RADIANCE II is a US Food and Drug Administration (FDA) investigational device exemption (IDE) study.
In the randomised, sham-controlled trial, which was held at multiple centres across eight countries, a total of 1,038 patients were assessed for eligibility. Out of these, 224 individuals with uncontrolled hypertension were randomly grouped in a 2:1 ratio to receive the Paradise uRDN or a sham.
Otsuka Medical Devices said that unless certain BP criteria were surpassed, patients were refrained from using antihypertensive drugs for two months of follow-up.
According to the results, patients using the Paradise uRDN system saw a decrease in daytime ambulatory systolic blood pressure, which averaged -7.9mmHg. This is in comparison to a decrease of -1.8mmHg in the sham arm.
Otsuka Medical Devices said that the between-group difference of -6.3mmHg is statistically significant.
The findings of the RADIANCE II trial also revealed similar reductions in blood pressure in measurements taken at nights and at 24 hour-intervals at home and at the doctor’s office.
Furthermore, Otsuka Medical Devices stated that no major adverse incidents were reported at 30 days.
The company said that the primary safety endpoint will be measured at six months and a follow-up of patients will be made for 60 months.
Otsuka Medical Devices executive deputy president Kazumichi Kobayashi said: “The results represent progress toward establishing a new treatment option for patients with hypertension.
“Through our global R&D efforts, we will continue to develop unique solutions for patients whose medical needs and conditions have not yet been met by existing treatments.”
The latest results follow an announcement made by Otsuka Medical Devices’ fully-owned US-based subsidiary ReCor Medical in July 2022 that the RADIANCE II trial met its primary efficacy endpoint.