Recor Earns First FDA OK for Renal Denervation to Treat High Blood Pressure

Recor Medical and parent company Otsuka Medical Devices revealed that the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise ultrasound renal denervation (RDN) system to treat hypertension.
 
The company explained the system is meant as an adjunctive treatment option when lifestyle changes when lifestyle changes and medications haven’t properly controlled the patient’s blood pressure. The ultrasound-RDN lowers blood pressure by denervating sympathetic nerves around the renal arteries, lowering the overactivity that can lead to high blood pressure.
 
“It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” site principal investigator Naomi Fisher, MD, Associate Professor of Medicine, Harvard Medical School, and Director of Hypertension Service and Hypertension Innovation, Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital, told the press.
 
Paradise delivers two to three doses of 360-degree ultrasound that last seven seconds each through the main renal arteries to the surrounding nerves. Its catheter also features Recor’s HydroCooling, which circulates sterile water through the balloon catheter during the surgery to protect the wall of the renal artery.
 
The Paradise ultrasound RDN met both primary safety and effectiveness endpoints without major adverse events in Recor’s RADIANCE II U.S. pivotal study, the company said. The company has been developing and testing Paradise to treat hypertension since 2009. Its safety and efficacy endpoints for hypertension were also met in the RADIANCE-HTN SOLO trial for mild-moderate hypertension patients in an “off-meds” setting, and RADIANCE-HTN TRIO for resistant hypertension patients on standardized antihypertensive therapy.
 
“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” said Recor president and CEO Lara Barghout. “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”
 
The Paradise system also has CE mark approval and is an investigational device in Japan.