FDA Clears Recor Medical’s Paradise™ Ultrasound RDN System for Treating Hypertension

Recor Medical, an Otsuka Medical Devices company, has received FDA clearance for the Paradise™ Ultrasound Renal Denervation (RDN) System for the treatment of hypertension.

The Paradise System is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. It is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

The Paradise System delivers two to three doses of 360-degree ultrasound energy – each lasting seven seconds – through each of the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.

Hypertension is the leading cause of disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and higher costs to health systems. The Paradise Ultrasound RDN system has previously received CE Mark and has been successfully launched in Europe and is an investigational device in Japan.

To view the source version, please click HERE.