PALO ALTO, Calif.--(BUSINESS WIRE)--Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) system as a treatment for hypertension. Analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group. The results were presented in a late-breaking session at Transcatheter Cardiovascular Therapeutics (“TCT”) — the annual scientific symposium of the Cardiovascular Research Foundation — by RADIANCE study co-principal investigator Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. The study results were simultaneously published in Circulation.
The RADIANCE Pooled Analysis includes data collected through six months follow-up from 506 patients randomized in the 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 2 to 5 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 6 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 6 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.
“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 6 months even with a backdrop of intensive monthly escalation of medications to try to achieve blood pressure control,” said Dr. Kirtane. “These data support the role of uRDN as a useful adjunct to established antihypertensive therapies.”
“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.
About Recor Medical, Inc.
Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in the United States and Japan and bears the CE mark. 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 the UK, with plans to expand globally.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of 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. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).