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

Autor: Haberman D; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA., Chitturi KR; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA., Lupu L; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA., Wermers JP; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA., Waksman R; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA.
Jazyk: angličtina
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2024 Jul; Vol. 104 (1), pp. 34-43. Date of Electronic Publication: 2024 May 07.
DOI: 10.1002/ccd.31065
Abstrakt: 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.
(© 2024 Wiley Periodicals LLC.)
Databáze: MEDLINE
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