Recor Medical’s Paradise uRDN System Evaluated in 6-Month Data From RADIANCE Pooled Analysis

November 3, 2023—Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., recently announced positive results from a combined analysis of 6-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension.

According to the company, the RADIANCE Pooled Analysis demonstrated blood pressure (BP) reduction was maintained after treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group.

The analysis includes data collected through 6-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.

Ajay Kirtane, MD, presented the findings in a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. The study results were simultaneously published by Michel Azizi, MD, et al online in Circulation.

Dr. Kirtane and Dr. Azizi serve as coprincipal investigators of the RADIANCE study. Dr. Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital in New York, New York. Dr. Azizi is Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France.

The analysis was summarized by the company in its press release as follows:

• After the 2-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 mm Hg, under continuous blinding.
• The combined analysis demonstrated that 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 mm Hg (P = .033) favoring uRDN.
• Differences in office and home systolic blood pressure through 6 months were -5.4 mm Hg (P < .001) and -5.2 mm Hg (P < .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,” commented Dr. Kirtane in the Recor press release. “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.”

Dr. Kirtane concluded, “These data support the role of uRDN as a useful adjunct to established antihypertensive therapies.”

Also commenting in the Recor press release, Dr. Azizi stated, “Following the 2-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 mm Hg 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.”

Dr. Azizi added, “The maintained reductions in BP provide further evidence of the effectiveness of uRDN as an additional therapy option for treating patients with uncontrolled hypertension.”

The Paradise uRDN system has received CE Mark approval for the treatment of hypertension in Europe. Recor has begun the Global Paradise System (“GPS”) Registry in the European Union and the United Kingdom, with plans to expand globally.

The Paradise uRDN system is an investigational device in the United States and Japan.

On August 22, 2023, a panel convened to advise the FDA on the safety and efficacy of renal denervation for patients with uncontrolled hypertension and largely voted in support of Recor Medical’s Paradise uRDN platform. Cardiac Interventions Today news coverage of that panel meeting is available online here.