Recor Medical and its parent company, Otsuka Medical Devices, said the FDA Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the 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.
The PMA submission included data from three clinical trials in the company’s RADIANCE Global Program, all of which are independently powered, randomized sham-controlled clinical trials of the Paradise Ultrasound RDN system. The studies included more than 500 patients with mild-to-moderate or resistant uncontrolled hypertension.
The Paradise Ultrasound RDN system bears the CE mark for the treatment of hypertension and is an investigational device in the United States and Japan.
