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# ReCor Medical ‘Breakthrough’ for Hypertension Device
- URL: https://www.fdaweb.com/recor-medical-breakthrough-for-hypertension-device/
- Published: 2020-12-11T12:00:00.000Z
- Updated: 2026-09-14T16:39:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148287

FDA has granted ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treating patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The designation is based on recent positive data from the RADIANCE-HTN TRIO study, according to the company. The catheter-based system is designed to denervate the renal nerves with ultrasound energy to reduce blood pressure in hypertensive patients. The trial met its primary efficacy endpoint of a greater reduction in daytime blood pressure between baseline and two-month follow-up with the device compared to a sham procedure, ReCor says.