FDA OKs Paradise Renal Denervation System for Hypertension

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After a positive FDA panel review in August, the FDA has approved the Paradise Ultrasound Renal Denervation system for the treatment of hypertension, manufacturer Recor and parent company Otsuka announced.

Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit.The US Food and Drug Administration has approved the Paradise Ultrasound Renal Denervation system for the treatment of hypertension, Recor Medical Inc and parent company Otsuka Medical Devices Co, Ltd, have announced.

The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds. Ultrasound renal denervation"has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure," Fisher added.

 

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