Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System

Dan Haberman; Kalyan R Chitturi; Lior Lupu; Jason P Wermers; Ron Waksman

doi:10.1002/ccd.31065

Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System

Catheter Cardiovasc Interv. 2024 May 7. doi: 10.1002/ccd.31065. Online ahead of print.

Authors

Dan Haberman¹, Kalyan R Chitturi¹, Lior Lupu¹, Jason P Wermers¹, Ron Waksman¹

Affiliation

¹ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA.

PMID: 38713867
DOI: 10.1002/ccd.31065

Abstract

Hypertension continues to be a prominent, avoidable factor contributing to major vascular issues on a global scale. Even with lifestyle adjustments and more aggressive medical treatments, maintaining optimal blood pressure levels remains challenging. This challenge has driven the emergence of device-oriented approaches to address hypertension. To assess the safety and efficacy of the Recor Paradise Ultrasound Renal Denervation System, the Circulatory System Devices Panel was convened by the US Food and Drug Administration (FDA). This manuscript provides a condensed overview of the information put forth by the sponsor and the FDA, along with an account of the considerations and conversations that took place during the meeting.

Keywords: clinical trials; comparative effectiveness/patient‐centered outcomes research; hypertension; interventional devices/innovation; sympathetic denervation.

Publication types

Review