ReCor Medical’s Paradise uRDN System Submitted to FDA for Approval

November 29, 2022—ReCor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., announced the filing of the premarket approval application to the FDA for the Paradise ultrasound renal denervation (uRDN) system in the treatment of uncontrolled hypertension.

The Paradise uRDN system has received CE Mark approval for the treatment of hypertension in Europe. It is an investigational device in the United States and Japan.

According to the company, the Paradise uRDN system uses a combination of ultrasound energy to denervate the renal nerves and a water-filled balloon to protect the renal artery. The device is used in an interventional procedure in which the Paradise catheter is placed in each of the main renal arteries, and then two to three 7-second ultrasound emissions are delivered to denervate the surrounding renal nerves, thereby reducing blood pressure.

ReCor noted that it has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, ReCor has begun the GPS (Global Paradise System) Registry in the European Union, with plans to expand globally.

The three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN system in more than 500 patients with uncontrolled hypertension are RADIANCE-HTN SOLO, RADIANCE-HTN TRIO, and RADIANCE II. Each trial met its prespecified primary efficacy endpoint of blood pressure reduction with positive safety.

RADIANCE II is the United States pivotal trial conducted under an FDA investigational device exemption.

ReCor announced in September that the RADIANCE II trial successfully reached its primary efficacy endpoint. Results showed a reduction in daytime systolic ambulatory blood pressure of –7.9 mm Hg in those treated with uRDN and a difference between uRDN and sham of –6.3 mm Hg (P < .0001). The results from the three RADIANCE clinical trials have been included in the submission for approval to the FDA.

Also, the company recently announced that results from an analysis of the pooled data from RADIANCE global clinical trial program were presented by Ajay Kirtane, MD, at the American Heart Association Scientific Sessions 2022 held November 5-7 in Chicago, Illinois.