The approval was based on the results from the (RADIANCE II) trial evaluating the safety & effectiveness of the Paradise system in patients with hypertension. The results from the trial were published in “JAMA”
The (RADIANCE II) clinical trial is a part of Recor’s RADIANCE global program which incl. 3 independent trials in 500 patients incl. (RADIANCE II) & (RADIANCE-HTN SOLO) for mild-moderate hypertension & (RADIANCE-HTN TRIO) for resistant hypertension
The Paradise system is an ultrasound-based RDN technology that lowers blood pressure by denervating sympathetic nerves around renal arteries, reducing hypertension, and features a HydroCooling system for sterile water circulation to help protect the renal artery wall
Ref: Businesswire | Image: ReCor Medical
Related News:- ReCor Medical Presents RADIANCE Clinical Trial Program Results of Paradise Ultrasound Renal Denervation System for Hypertension at AHA 2022
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