Ultrasound-based renal denervation system promising for treatment of hypertension: RADIANCE II Top-Line Results
USA: In patients with mild-to-moderate hypertension, the ultrasound-based Paradise system (ReCor Medical) for renal denervation was shown to significantly reduce daytime ambulatory systolic blood pressure at 2 months versus a sham procedure, show top-line results of the RADIANCE II trial -- a clinical trial required for US regulatory approval.
The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for treating patients with uncontrolled hypertension. It included 224 patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two medications. They were randomized while off medications at more than 60 study centers in 8 countries.
Kazumichi Kobayashi, Executive Deputy President of Otsuka Medical Devices who seemed very pleased with the positive outcome of the RADIANCE II study said in a press release, "With three successful clinical trials of the Paradise uRDN System, we believe even more strongly that the Paradise System can become an important treatment option for patients and physicians struggling to control blood pressure."
"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 M. Weiss.
RADIANCE II is the third and largest component of ReCor's RADIANCE Global Program—randomized and sham-controlled studies evaluating the Paradise uRDN System in hypertension patients. The first two studies in the series are the previously reported RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those who remained hypertensive despite being on antihypertensive therapy).
The primary effectiveness endpoints was met by both the studies. With RADIANCE II, ReCor now has a third positive trial, with more than 500 patients randomized in the RADIANCE Global Program. ReCor has also begun the Global Paradise System ("GPS") Registry—a real-world study of up to 3,000 patients with uncontrolled hypertension.
To conclude, RADIANCE II US FDA IDE pivotal trial evaluating the Paradise Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.
