Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System. [Review] (Record no. 14547)

MARC details
000 -LEADER
fixed length control field 03440nam a22006737a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 240807s20242024 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1522-1946
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 38713867
245 ## - TITLE STATEMENT
Title Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System. [Review]
251 ## - Source
Source Catheterization & Cardiovascular Interventions. 104(1):34-43, 2024 Jul.
252 ## - Abbreviated Source
Abbreviated source Catheter Cardiovasc Interv. 104(1):34-43, 2024 Jul.
253 ## - Journal Name
Journal name Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2024
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2024
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Publication date 2024 Jul
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Medline status MEDLINE
266 ## - Date added to catalog
Date added to catalog 2024-08-07
266 ## - Date added to catalog
Date Medline record created 2024/05/07 15:23
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
520 ## - SUMMARY, ETC.
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. Copyright © 2024 Wiley Periodicals LLC.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Blood Pressure
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Device Approval
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Hypertension
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Renal Artery
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Sympathectomy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *United States Food and Drug Administration
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Advisory Committees
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Equipment Design
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hypertension/pp [Physiopathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hypertension/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Kidney/bs [Blood Supply]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Renal Artery/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Renal Artery/ir [Innervation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Risk Factors
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Sympathectomy/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Sympathectomy/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Indexing Automated
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Advanced Cardiac Catheterization Research Fellowship R
656 ## - INDEX TERM--OCCUPATION
Department Interventional Cardiology Fellowship
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
657 ## - INDEX TERM--FUNCTION
Medline publication type Review
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Chitturi, Kalyan
Institution Code MWHC
Program Advanced Cardiac Catheterization Research Fellowship
Degree DO
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Haberman, Dan
Institution Code MWHC
Program Interventional Cardiology Fellowship
Degree MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Lupu, Lior
Institution Code MWHC
Program Interventional Cardiology Fellowship
Degree MBA, MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Wermers, Jason P
Institution Code MHVI
790 ## - Authors
All authors Haberman D, Chitturi KR, Lupu L, Wermers JP, Waksman R
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1002/ccd.31065">https://dx.doi.org/10.1002/ccd.31065</a>
Public note https://dx.doi.org/10.1002/ccd.31065
858 ## - ORCID
ORCID text Waksman, Ron
Orcid <a href="http://orcid.org/0000-0002-4063-9226">http://orcid.org/0000-0002-4063-9226</a>
Name http://orcid.org/0000-0002-4063-9226
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Barcode Date last seen Price effective from Koha item type
              08/07/2024   38713867 08/07/2024 08/07/2024 Journal Article

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