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PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ ReCor Medical, Inc. ( ReCor ), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the Paradise System ) demonstrated positive results in the RADIANCE-HTN TRIO ( TRIO ) study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
The RADIANCE-HTN TRIO trial evaluated the efficacy and safety of the Paradise System – a catheter-based system designed to denervate the renal nerves with ultrasound energy – to reduce blood pressure in hypertensive patients (n=136) wherein all subjects were placed on a single-pill combination-drug containing 3 anti-hypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a d