TY  - BOOK
AU  - Chitturi, Kalyan
AU  - Haberman, Dan
AU  - Lupu, Lior
AU  - Waksman, Ron
AU  - Wermers, Jason P
TI  - Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System. [Review]
SN  - 1522-1946
PY  - 2024///
KW  - *Blood Pressure
KW  - *Device Approval
KW  - *Hypertension
KW  - *Renal Artery
KW  - *Sympathectomy
KW  - *United States Food and Drug Administration
KW  - Advisory Committees
KW  - Equipment Design
KW  - Humans
KW  - Hypertension/pp [Physiopathology]
KW  - Hypertension/su [Surgery]
KW  - Kidney/bs [Blood Supply]
KW  - Renal Artery/dg [Diagnostic Imaging]
KW  - Renal Artery/ir [Innervation]
KW  - Risk Factors
KW  - Sympathectomy/ae [Adverse Effects]
KW  - Sympathectomy/is [Instrumentation]
KW  - Treatment Outcome
KW  - United States
KW  - Automated
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Advanced Cardiac Catheterization Research Fellowship R
KW  - Interventional Cardiology Fellowship
KW  - Journal Article
KW  - Review
N1  - Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
N2  - 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. Copyright © 2024 Wiley Periodicals LLC
UR  - https://dx.doi.org/10.1002/ccd.31065
ER  -