In a significant development for the management of hypertension, the US Food and Drug Administration (FDA) has granted approval to the Paradise Ultrasound Renal Denervation (RDN) system. The announcement was made by Recor Medical, Inc. and its parent company Otsuka Medical Devices on November 7, 2023. This approval follows positive votes by the FDA’s Circulatory System Devices Panel (CSDP) in late August 2023 and is based on data from the RADIANCE II trial.
The Paradise Ultrasound RDN system, developed and tested since 2009, delivers 2 to 3 doses of 360-degree ultrasound energy through each of the main renal arteries to surrounding nerves. Notably, the system features an exclusive HydroCooling system to protect the renal artery wall by circulating sterile water during the procedure.
The RADIANCE II trial, a sham-controlled, randomised clinical trial, involved 124 patients with resistant or moderate hypertension. Results indicated a substantial reduction in daytime ambulatory systolic blood pressure (SBP) in the ultrasound renal denervation group compared to the sham group. The primary safety outcomes showed no major adverse events in either group.
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Dr. Naomi Fisher, the site principal investigator, emphasised the significance of the Paradise Ultrasound RDN system in providing a much-needed advancement in hypertension control, particularly for patients with resistant hypertension.
Lara Barghout, President and CEO of Recor Medical, expressed gratitude to patients and clinical trial investigators, highlighting the years of technical research and rigorous clinical studies that led to FDA approval. The Paradise Ultrasound RDN system's benefits were deemed to outweigh the risks, with committee members voting in favour of safety and efficacy during the August 22, 2023 CSDP meeting.
This FDA approval marks a milestone in hypertension treatment, offering a promising alternative for patients struggling to control blood pressure. Recor Medical looks forward to making this innovative technology available to physicians and patients nationwide.
