Recor Medical, along with its parent company Otsuka Medical Devices, has received approval from the US Food and Drug Administration (FDA) for the Paradise Ultrasound Renal Denervation (RDN) system to treat hypertension.
Paradise is claimed to be the first-of-its-kind ultrasound-based RDN technology intended for reducing blood pressure by denervating the sympathetic nerves that surround the renal arteries.
The system administers two to three seven-second doses of 360° ultrasound energy through each of the main renal arteries to the surrounding nerves.
The Paradise catheter comes with the exclusive HydroCooling system that facilitates the circulation of sterile water through the balloon catheter at the time of the procedure to protect the renal artery wall.
It was approved after receiving a favourable recommendation from the FDA Advisory Committee Panel in August 2023.
The system is designed as an adjunctive treatment option when lifestyle changes and medications are insufficient for controlling the blood pressure of a patient.
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Recor Medical president and CEO Lara Barghout said: “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.”
In the RADIANCE II randomised clinical trial, the Paradise Ultrasound RDN system achieved both the primary safety and effectiveness endpoints and no major adverse events were observed, according to the company.
The RADIANCE global programme evaluated the Paradise system in three sham-controlled, independently powered, randomised clinical studies in more than 500 patients with uncontrolled hypertension.
Each trial attained its prescribed primary efficacy endpoint with a positive safety profile consistently observed after ultrasound RDN therapy.