The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee yesterday (22 August) voted that there is sufficient data to support the use of the Paradise ultrasound renal denervation system (Recor Medical) in patients with uncontrolled hypertension.
The committee voted 12 to 0 in favour of the Paradise ultrasound renal denervation system with regard to safety and eight to three in favour with regard to efficacy, with one vote abstaining. The committee also voted 10 to two in favour that the Paradise system benefits outweigh the risks.
If approved by the FDA, the Paradise ultrasound renal denervation system could be the first FDA-approved renal denervation device in the USA 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 Ajay Kirtane (Columbia University/NewYork-Presbyterian Hospital, New York, USA) who serves as co-primary investigator in the RADIANCE Global programme studying the Paradise system. “I was pleased to see that the advisory committee recognised the adjunctive benefits of the Paradise ultrasound renal denervation system in lowering blood pressure—something that we sought to demonstrate definitively through the generation of high-level scientific evidence within the RADIANCE Global programme.”
“We are thankful to the FDA and advisory committee members for the thoughtful review and discussion of the Paradise system for the treatment of uncontrolled hypertension,” said Lara Barghout, president and chief executive officer, Recor Medical. “We will continue to work closely with the FDA in advance of our anticipated premarket approval and feel confident in the impact that Paradise ultrasound renal denervation could have in addressing a significant unmet need.”
The premarket approval submission included data from three clinical trials in the company’s RADIANCE Global programme, all of which are independently powered, randomised sham-controlled clinical trials of the Paradise ultrasound renal denervation system. The studies included more than 500 patients with mild-to-moderate or resistant uncontrolled hypertension.
The Paradise ultrasound renal denervation system bears the CE mark for the treatment of hypertension and is an investigational device in the USA and Japan.