As expected, the FDA approved the Paradise ultrasound renal denervation system as an adjunctive treatment for hypertension, giving patients another option to control their blood pressure (BP), Recor Medical announced on Tuesday.
The Paradise device, which delivers ultrasound pulses through each of the main renal arteries to the surrounding nerves, is indicated when lifestyle changes and medications have not adequately controlled hypertension.
“Despite the longstanding availability of dozens of affordable anti-hypertensive medications, blood pressure control rates in the United States are alarmingly low and falling,” said Naomi Fisher, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, in Recor’s press release. “Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension.”
The benefits of catheter-based ultrasound renal denervation were demonstrated in three randomized, sham-controlled trials in patients with mild-to-moderate and resistant hypertension.
In people with mild-to-moderate and stage II hypertension who discontinued their BP medications, the RADIANCE-HTN SOLO and RADIANCE II trials showed an average 6.3 mm Hg lower daytime ambulatory systolic BP at 2 months after the Paradise procedure compared with sham. For peers with resistant hypertension despite staying on at least three antihypertensives in RADIANCE-HTN TRIO, Paradise’s BP reduction amounted to 4.5 mm Hg over controls.
Besides the modest efficacy, the safety of the Paradise renal denervation procedure was also supported by all three trials.
The FDA approval follows an advisory committee’s favorable 10-2 vote for the Paradise system in August.
The device’s approval marks the end of renal denervation’s long journey to the U.S. market. Nearly a decade ago, the early enthusiasm for this technology soured when the SYMPLICITY HTN-3 trial failed to show that a first-generation system could beat sham in lowering office-based BP measurements. Industry had since learned its lesson and worked with the FDA to better design future trials.
The Paradise ultrasound renal denervation system is already on the market in Europe and remains an investigational device in Japan.