Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System.
clinical trials
comparative effectiveness/patient‐centered outcomes research
hypertension
interventional devices/innovation
sympathetic denervation
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
07 May 2024
07 May 2024
Historique:
revised:
07
03
2024
received:
08
12
2023
accepted:
17
04
2024
medline:
7
5
2024
pubmed:
7
5
2024
entrez:
7
5
2024
Statut:
aheadofprint
Résumé
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.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
US Food and Drug Administration. Circulatory system devices panel of the medical devices advisory committee meeting announcement. Accessed October 3, 2023. August 22‐23, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/august-22-23-2023-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting
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