Catalyst
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ReCor Medical Announces IDE Approval for RADIANCE-HTN Hypertension Clinical Trial
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Additional Information
RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.RADIANCE-HTN will be led by two Co-Primary Investigators (Co-PIs): Professor Michel Azizi, MD PhD (Georges Pompidou Hospital,Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women's Hospital, Boston, MA). The study is approved to enroll 292 patients at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands. Initial patient enrollment is anticipated in the first quarter of 2016.
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Catalyst Date
Occurred on:
Feb 22, 2016
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Related Keywords
Ide Approval, Radiance-htn, Hypertension, Renal Denervation System, Recor Paradise