The RADIANCE II is a randomised, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of uncontrolled hypertension
The RADIANCE II trial evaluating the Paradise uRDN System as a treatment for hypertension met its primary efficacy endpoint. (Credit: Ewa Urban from Pixabay)
ReCor Medical and Otsuka Medical Devices have announced the results from RADIANCE II US FDA IDE pivotal trial evaluating the Paradise Ultrasound Renal Denervation (uRDN) System.
The ReCor Paradise uRDN System, designed for the treatment of hypertension, met its primary efficacy endpoint in the trial.
It showed a reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.
The RADIANCE II US FDA IDE pivotal trial is a randomised, sham-controlled clinical trial intended to evaluate the ReCor Paradise uRDN System in the treatment of uncontrolled hypertension.
At more than 60 trial locations in eight countries, 224 patients with mild-to-moderate uncontrolled hypertension who had previously been treated with up to two drugs were randomly assigned.
ReCor president and CEO Andrew Weiss said: “ReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint.
“Following the positive SOLO and TRIO clinical trials, RADIANCE II adds to the evidence for the Paradise System as a potential future treatment for patients with uncontrolled hypertension.
“We would like to express our gratitude to the Principal Investigators, Steering Committee and all investigators for their efforts throughout this important trial.”
RADIANCE II, the third and largest part of ReCor’s RADIANCE Global Program, consists of randomised, sham-controlled trials assessing the Paradise uRDN System in hypertensive patients.
The previously announced RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO investigations are the first two in the series (conducted in those who remained hypertensive despite being on antihypertensive therapy).
The key efficacy endpoints of both trials were fulfilled.
ReCor currently has a third successful study with RADIANCE II, and the RADIANCE Global Program has randomised more than 500 participants.
The company has also started the Global Paradise System (“GPS”) Registry, a real-world trial including up to 3,000 patients with uncontrolled hypertension.