FDA Advisory Committee recommends Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension

The overall vote from the committee was favorable that there was sufficient data to support the use of the device in patients with uncontrolled hypertension. The committee voted 12 to 0 in favor of the Paradise Ultrasound RDN system with regard to safety and 8 to 3 in favor with regard to efficacy, with one vote abstaining. The committee also voted 10 to 2 in favor that the Paradise system benefits outweigh the risks.

If approved by the FDA, the Paradise Ultrasound RDN system could be the first FDA-approved renal denervation device in the U.S. indicated to reduce blood pressure in patients with uncontrolled hypertension.

“Hypertension is one of the leading causes of cardiovascular morbidity and mortality, and despite the widespread availability of effective medications and lifestyle modification, rates of blood pressure control are still poor,” said Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital, who serves as co-primary investigator in the RADIANCE Global Program studying the Paradise system. “I was pleased to see that the advisory committee recognized the adjunctive benefits of the Paradise Ultrasound RDN system in lowering blood pressure – something that we sought to demonstrate definitively through the generation of high-level scientific evidence within the RADIANCE Global Program.”