FDA Approves First Renal Denervation System for Hypertension
9 Nov 2023 • The US Food and Drug Administration has given its nod to the Paradise renal denervation system, an innovative ultrasound-based treatment for hypertension. Serving as an adjunctive option when lifestyle changes and medications fall short in controlling BP, Paradise utilizes 360-degree ultrasound energy to denervate sympathetic nerves around renal arteries, reducing the overactivity that can lead to hypertension.
The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment.
Source: Diagnostic & Interventional Cardiology | Read full story