FDA Approves Recor Medical's Paradise Ultrasound Renal Denervation System

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved the Paradise Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Announced by Recor Medical, Inc. and its parent company Otsuka Medical Devices on November 7, 2023, the approval is based on data from the RADIANCE II trial and comes less than 3 months after a series of positive votes by the FDA’s Circulatory System Devices Panel (CSDP) in late August 2023.^1,2

“Despite the longstanding availability of dozens of affordable anti-hypertensive medications, blood pressure control rates in the United States are alarmingly low and falling. Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” said site principal investigator Naomi Fisher, MD, associate professor of medicine at Harvard Medical School, and director of Hypertension Service and Hypertension Innovation in the Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital.¹ “uRDN has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure.”

According to Recor Medical, the development and testing of the system dates back to 2009. The system itself delivers 2 to 3 doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves. The company also pointed out the system’s catheter also features catheter features the exclusive HydroCooling system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.¹

The RADIANCE II trial, which was used as the basis for the FDA”s approval, was a sham-controlled, randomized (2:1) clinical trial conducted at 37 centers in the US and 24 centers in Europe. For inclusion, patients were required to have an ambulatory systolic blood pressure (SBP and diastolic blood pressure (DBP) of 135/85 mmHg or greater and an SBP/DBP less than 170/105 mmHg after a 4-week washout of their medications. Additional inclusion criteria required patients to have an eGFR of 40 mL/min/1.73 m2 or greater and suitable renal artery anatomy.³

A total of 124 patients were randomized 2:1 undergo ultrasound renal denervation or a sham procedure. This cohort had a mean age, 55 years (Standard Deviation [SD], 9.3 years), 28.6% were female, and 16.1% self-identified as Black or African American. These patients were followed for primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months.³

Results of the trial suggested the reductions in daytime ambulatory SBP observed in the trial were greater among the ultrasound renal denervation group (mean, −7.9 mm Hg; SD, 11.6 mmHg) than among those in the sham group (mean, −1.8 mmHg; SD, 9.5 mmHg) (baseline-adjusted between-group difference, −6.3 mmHg; 95% CI, −9.3 to −3.2 mmHg; P < .001). Investigators pointed out 6 of the study’s 7 secondary blood pressure outcomes were significantly improved with ultrasound renal denervation relative to the sham group and no major adverse events were reported in either group.³

The Paradise Ultrasound RDN system was the subject of an August 22, 2023 CSDP meeting. In that meeting, committee members voted 12 to 0 in favor of the Paradise Ultrasound system for safety and 8 to 3 in favor of efficacy, with a single vote abstaining. When asked about the benefit-risk profile, the committee voted 10 to 2 in favor of the Paradise system's benefits outweighing the risks.³

“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” said Lara Barghout, president and chief executive officer of Recor Medical.¹ “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”

References:

1. Recor Medical. Recor Medical and Otsuka Medical Devices announce first FDA-approved renal denervation system for the treatment of hypertension. Recor Medical. November 7, 2023. Accessed November 8, 2023. https://www.recormedical.com/recor-medical-and-otsuka-medical-devices-announce-first-fda-approved-renal-denervation-system-for-the-treatment-of-hypertension/.
2. Iapoce C. FDA Advisory Committee split on Renal Denervation Systems. HCP Live. August 24, 2023. Accessed November 9, 2023. https://www.hcplive.com/view/fda-advisory-committee-split-renal-denervation-systems.
3. Azizi M, Saxena M, Wang Y, et al. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023;329(8):651–661. doi:10.1001/jama.2023.0713