ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise® Ultrasound Denervation System For Treatment Of Hypertension
July 2, 2018
PALO ALTO, Calif., - ReCor Medical announced today that the US Food & Drug Administration approved the Company's new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II.
Building upon the recent positive results of the Company's RADIANCE-HTN SOLO study, 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 of this year.
"We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval," commented Leslie Coleman, Vice President of Regulatory & Medical Affairs. "At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages of hypertension - our SOLO, TRIO, REQUIRE, and RADIANCE-II studies - approaching a total of nearly 500 subjects, with outcomes as long as 3 years."
"Our Steering Committee and medical advisors have been instrumental in the design of the Global RADIANCE Clinical Program - including the RADIANCE-II pivotal study - for the US, Europe, Japan and Korea," added Helen Reeve-Stoffer, Vice President of Clinical Affairs. "Given the recent positive SOLO results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise System to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension."
About ReCor Medical, Inc.
ReCor Medical is a private, clinical-stage, medical device company that has developed the Paradise® System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN). RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions. The Paradise System bears a CE mark but is not approved for sale in the United States. ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe, the REQUIRE trial in Japan and Korea with its partner Otsuka, and recently received approval from the FDA to conduct RADIANCE-II as a pivotal study of the Paradise System.