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# FDA Approves Recor Paradise System
- URL: https://www.fdaweb.com/fda-approves-recor-paradise-system/
- Published: 2023-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:15:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155745

FDA has approved a PMA for Recor Medical’s Paradise ultrasound renal denervation system indicated to treat hypertension. The company [says](https://www.recormedical.com/recor-medical-and-otsuka-medical-devices-announce-first-fda-approved-renal-denervation-system-for-the-treatment-of-hypertension/?ref=fdaweb.com) Paradise is intended as an adjunct treatment when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. It is described as a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

Recor says that in the RADIANCE II clinical trial, the Paradise system met the primary safety and efficacy endpoints without any major adverse events. The system received a positive recommendation from the FDA Circulatory System Devices Panel in 8/2023\. In 2020, FDA granted the system a breakthrough device designation.