July 1, 2018
FDA Approves IDE for RADIANCE-II Trial of ReCor Medical's Paradise Ultrasound Denervation System to Treat Hypertension
July 2, 2018—ReCor Medical, Inc. announced that the US Food and Drug Administration (FDA) approved RADIANCE-II, the new pivotal study of the company's Paradise ultrasound denervation system for the treatment of hypertension.
RADIANCE-II will be a randomized, sham-controlled, blinded study in patients with moderate hypertension, powered to demonstrate the safety and efficacy of the Paradise system's ability to lower blood pressure. ReCor expects to initiate enrollment in RADIANCE-II in October 2018.
The company expects to build upon the recent results of the RADIANCE-HTN SOLO study to develop a robust set of clinical data to support the future FDA review of a premarket approval (PMA) application. The company plans that the PMA submission will include findings from four independently powered, blinded, sham-controlled, randomized studies (SOLO, TRIO, REQUIRE, and RADIANCE-II) of the Paradise system in patients with different stages of hypertension composed of a total of approximately 500 patients and outcomes out to as long as 3 years.
The Paradise system has received European CE Mark approval. In the United States, it is not approved for sale. ReCor is conducting the RADIANCE-HTN clinical trial in the United States and Europe under an FDA investigational device exemption. The REQUIRE trial is being conducted in Japan and Korea with Recor Medical's partner, Otsuka Holdings, advised the company.