FDA approves renal denervation for high blood pressure

American doctors finally have a new option for treating high blood pressure (hypertension) that remains insufficiently controlled despite medication and lifestyle changes.

The FDA has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) System. The Palo Alto, Calif.-based company’s RDN system is designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, thereby reducing hyperactivity that can lead to hypertension. The Paradise system is designed to deliver two to three doses of 360-degree ultrasound energy lasting seven seconds each through each of the main renal arteries to the surrounding nerves. The Paradise catheter features the company’s HydroCooling system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.

The approval isn’t a huge surprise, given the FDA’s advisory committee’s positive vote in August. But he pours a little salt into Medtronic’s kidney denervation wounds. Just one day after voting to approve the Paradise system, the same panel voted against Medtronic’s renal denervation system.

Earlier this year, results from the pivotal US Recors study, the RADIANCE II randomized trial, were published in the Journal of the American Medical Association (JAMA). In the study, Recor’s renal denervation system met primary safety and efficacy endpoints without any major adverse events.

Recor is leading the way in providing an innovative solution for clinicians and their patients who struggle to control their blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies, said Lara Barghout, CEO of Recor. We are grateful to the patients who participated in the studies and to the teams of clinical trial investigators whose diligence and dedication made FDA approval possible. We look forward to making this technology available to doctors and their patients across the country.

Recor has been developing the Paradise Renal Denervation System for the treatment of hypertension since 2009. The global RADIANCE program has studied the Paradise System in three independently controlled, randomized trials involving more than 500 patients with hypertension. uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild to moderate hypertension in a drug-free setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on triple therapy standardized antihypertensive drug. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following RDN ultrasound treatment.

Despite the long availability of dozens of affordable antihypertensive medications, blood pressure control rates in the United States are alarmingly low and declining. Given the significant reductions in blood pressure observed in ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation System offers a much-needed advancement in our currently available options for controlling hypertension, said site principal investigator Naomi Fisher, MD, associate professor of medicine at Harvard Medical School and director of Hypertension Service and Hypertension Innovation for the Division of Endocrinology, Diabetes, and Hypertension at Brigham and Womens Hospital. uRDN has been shown to be effective in patients with truly resistant hypertension, a population for whom drug treatment often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medications to control their blood pressure.

The Paradise system has already been introduced in Europe under the CE marking and is an experimental device in Japan.