Recor Medical announced the first commercial uses of Recor’s Paradise Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States.
The Paradise system received FDA approval on Nov. 7 as an ultrasound-based renal denervation (RDN) technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries. Paradise uRDN delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling system, which circulates sterile water through the balloon during the procedure to help cool and protect the inner layers of the renal artery.
The Paradise uRDN system is now available as an adjunct treatment option for patients who have been unable to achieve blood pressure goals with standard lifestyle changes and oral medications.
The Paradise uRDN system was tested through Recor’s RADIANCE Global Program of three rigorous prospectively powered and sham-controlled randomized controlled clinical trials: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension. Each trial successfully met its prespecified primary efficacy endpoint, showing statistically significant and clinically meaningful blood pressure reductions compared to a sham arm and favorable safety profiles.
