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 The leading web portal for pharmacy resources, news, education and careers August 19, 2018
Pharmacy Choice - Pharmaceutical News - ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise Ultrasound Denervation System For Treatment Of Hypertension - August 19, 2018

Pharmacy News Article

 7/22/18 - ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise Ultrasound Denervation System For Treatment Of Hypertension

By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA ReCor Medical announced 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 (see also ReCor Medical Inc.).

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."

Keywords for this news article include: Business, FDA Actions, Hypertension, ReCor Medical Inc, Health and Medicine, Cardiovascular Diseases and Conditions.

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