Core Concepts
ReCor Paradise Ultrasound Renal Denervation System deemed safe and effective by FDA panel.
Abstract
The FDA's Circulatory System Devices Panel reviewed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System for adults with uncontrolled hypertension. The device is intended for renal arteries with specific diameters. While most panel members agreed on the device's safety, some expressed concerns about its long-term efficacy. Data from trials showed a significant initial drop in blood pressure, but the advantage diminished over time. The panel emphasized the need for further studies in specific subpopulations affected by hypertension.
Stats
The device is intended for renal arteries with diameters of 3.0 to 8.0 mm.
Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy.
At 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device.
By 6 months, there was only a 1 mm Hg difference in blood pressure between the two groups.
Quotes
"The benefit is more short term, it is unclear what the long term benefit would be." - Benjamin Saville, PhD
"The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly." - John Hirshfeld, Jr, MD
"Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines." - John Somberg, MD