The Paradise system is designed to be used as a supplementary treatment option when a patient's blood pressure has not been sufficiently managed by medicine and lifestyle changes
FDA approves the Paradise Ultrasound RDN system for the treatment of hypertension. (Credit: Myriams-Fotos from Pixabay)
Recor Medical, a subsidiary of Otsuka Medical Devices, has received the US Food and Drug Administration (FDA) approval for its Paradise Ultrasound Renal Denervation (RDN) system in hypertension treatment.
The Paradise system is designed to be used as a supplementary treatment option when a patient’s blood pressure has not been sufficiently managed by medicine and lifestyle changes.
Its RDN technology uses ultrasound to denervate the sympathetic nerves that surround the renal arteries, thereby lowering blood pressure and preventing hyperactivity that can lead to hypertension.
The medical technology company, which is focused on hypertension management, said that the system sends two to three doses of 360-degree ultrasound energy. These doses, which last for seven seconds, are delivered to the surrounding neurons through each of the major renal arteries.
The Paradise catheter is equipped with the HydroCooling system for pumping sterile water through the balloon catheter to help protect the renal artery wall throughout the procedure.
Recor Medical president and CEO Lara Barghout said: “This FDA approval is the culmination of years of technical research and rigorous clinical studies.
“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.”
The approval of the Paradise system was based on a positive opinion from the FDA Advisory Committee Panel in August 2023.
In the RADIANCE 2 randomised clinical trial, the Paradise Ultrasound RDN system achieved the study’s primary safety and effectiveness endpoints without any significant adverse episodes.
Otsuka Medical Devices president and representative director Noriko Tojo said: “Approval of the Paradise Ultrasound RDN system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension which remains inadequately controlled despite conventional therapies.”
The Paradise Ultrasound RDN system is an investigational device in Japan and has secured CE mark in Europe.
Last month, Recor Medical reported that the Paradise Ultrasound RDN system maintained blood pressure reduction in three RADIANCE global studies.