Recor Medical and Otsuka Medical Devices have introduced the FDA-approved 'First-of-Its-Kind' Renal Denervation System for Hypertension
Recor Medical, in collaboration with its parent company Otsuka Medical Devices, has received FDA approval for the Paradise™ Ultrasound Renal Denervation (RDN) system, marking a significant development in hypertension treatment. This groundbreaking system is designed as an additional option for patients whose blood pressure remains inadequately controlled despite lifestyle changes and medications.
The Paradise system utilizes a unique ultrasound-based RDN technology to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, addressing the overactivity associated with hypertension. Administering two to three doses of 360-degree ultrasound energy through each main renal artery, each lasting seven seconds, the system includes the exclusive HydroCooling™ system. This system circulates sterile water during the procedure to safeguard the renal artery wall.
Recor aims to provide a novel solution for clinicians and patients grappling with blood pressure control. Despite the availability of numerous affordable anti-hypertensive medications, the Paradise Ultrasound Renal Denervation system offers a promising advancement, demonstrated by significant blood pressure reductions in clinical trials.
This FDA approval is a crucial milestone for Recor, introducing a new adjunctive treatment option for hypertension, a global health concern linked to increased cardiovascular morbidity and mortality, diminished quality of life, and heightened healthcare costs.