ReCor Medical and Otsuka Medical Devices, a wholly-owned subsidiary of Otsuka Holdings, have reported positive data from the RADIANCE II US FDA investigational device exemption (IDE) pivotal trial of the Paradise Ultrasound Renal Denervation (uRDN) System.
The Paradise uRDN System is currently an investigational device in the US and has also received CE mark in the EU.
The randomised, sham-controlled RADIANCE II US FDA IDE pivotal clinical trial was designed to demonstrate the effectiveness of the Paradise uRDN System to treat uncontrolled hypertension, as well as provide additional information on the device’s ability.
It was conducted in 224 mild-to-moderate uncontrolled hypertension patients, who received prior treatment with up to two medications and were randomised while off medications, at more than 60 study centres across eight countries.
The findings demonstrated that the trial met its primary efficacy endpoint and, when compared to a sham procedure, showed a significant reduction in daytime ambulatory systolic blood pressure at two months following treatment with the Paradise system.
ReCor president and CEO Andrew Weiss said: “ReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint.
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“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.”
The company stated that the RADIANCE II pivotal trial represents the third and largest component of its Radiance Global Programme of randomised and sham-controlled studies that are designed to assess the Paradise uRDN system for hypertension treatment.
The previous two studies, RADIANCE-HTN SOLO and TRIO, both met their primary effectiveness endpoints.
Additionally, the company has commenced the Global Paradise System (GPS) Registry, a real-world study, which will be conducted in up to 3,000 uncontrolled hypertension patients.
ReCor announced the completion of participant enrolment in the RADIANCE II pivotal trial in March.