Study: Paradise Ultrasound Renal Denervation System Helps Reduce Blood Pressure

Recor Medical Inc. and its parent company, Otsuka Medical Devices Co. Ltd. are touting positive results from several studies of the Paradise Ultrasound Renal Denervation (uRDN) system in treating hypertension. 

A combined analysis of six-month follow-up data from three RADIANCE global clinical studies demonstrated maintained blood pressure (BP) reduction after treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group. The study results have been published in Circulation.
 
“One of the key questions often asked about renal denervation is whether it is durable, especially in comparison to (or in combination with) antihypertensive medications. In this pooled analysis from the three sham-controlled clinical trials in the RADIANCE program, we observed a continued effect of uRDN at six months even with a backdrop of intensive monthly escalation of medications to try to achieve blood pressure control,” said RADIANCE study co-principal investigator Dr. Ajay Kirtane, professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. “These data support the role of uRDN as a useful adjunct to established antihypertensive therapies.”

The RADIANCE Pooled Analysis includes data collected through six months follow-up from 506 patients randomized in three studies from Recor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. Following the two-month primary endpoint for each study, if monthly home BP was uncontrolled from two to five months after randomization, medical antihypertensive treatments were sequentially added for both treated and sham groups to try to achieve a home BP reading of <135/85 mmHg, under continuous blinding. The combined analysis demonstrated fewer medications were added in the uRDN group at six months compared to sham. The difference in daytime ambulatory systolic blood pressure between groups after adjusting for the difference in medications was -3.0 mmHg (p=0.033) favoring uRDN. Similarly, office and home systolic blood pressure differences over six months were -5.4 mmHg (p<0.001) and -5.2 mmHg (p<0.001), respectively. Safety outcomes were few and did not differ between the groups.
 
“Following the two-month primary endpoint period for each RADIANCE study, our goal was to add antihypertensive medications for each patient with still uncontrolled BP to drive their BP to control, or less than 135/85 mmHg by home BP measurement. Notably, fewer medications were added in fewer patients in the uRDN group while they also achieved a significantly lower average BP than the sham group,” said co-principal investigator Michel Azizi, professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. “The maintained reductions in BP provide further evidence of the effectiveness of uRDN as an additional therapy option for treating patients with uncontrolled hypertension.”
 
Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost to health systems.
 
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.
 
Headquartered in Palo Alto, Calif., Recor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co.,Ltd., that is focused on transforming hypertension management. Recor has pioneered use of the Paradise Ultrasound Renal Denervation system for treating hypertension. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (GPS) Registry in the European Union and United Kingdom, with plans to expand globally.
 
Otsuka Medical Devices develops and commercializes medical care products including endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co. Ltd., a global healthcare company listed on the Tokyo Stock Exchange.