Otsuka (OTCPK:OTSKF) (OTCPK:OTSKY) said its Paradise Ultrasound Renal Denervation (uRDN) system met the main goal of trial evaluating the device to treat patients with uncontrolled hypertension ( high blood pressure).
The study, dubbed RADIANCE II US FDA IDE, met its main goal of showing a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.
Otsuka Medical and its unit ReCor Medical said that 224 patients with mild-to-moderate uncontrolled hypertension, who were previously treated with up to two medicines, were randomized while off medications at more than 60 study centers in eight countries.
RADIANCE II was the third and largest component of ReCor’s RADIANCE global program, which also included RADIANCE-HTN SOLO and TRIO. Both studies met their primary effectiveness goals, the companies added.
"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," said ReCor President and CEO Andrew Weiss.
ReCor noted that it has also begun Global Paradise System Registry—a real-world study of up to 3,000 patients with uncontrolled hypertension.