000			03440nam a22006737a 4500
008			240807s20242024 xxu||||| |||| 00| 0 eng d
022			_a1522-1946
040			_aOvid MEDLINE(R)
099			_a38713867
245			_aOverview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System. [Review]
251			_aCatheterization & Cardiovascular Interventions. 104(1):34-43, 2024 Jul.
252			_aCatheter Cardiovasc Interv. 104(1):34-43, 2024 Jul.
253			_aCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
260			_c2024
260			_fFY2024
260			_p2024 Jul
265			_sppublish
265			_tMEDLINE
266			_d2024-08-07
266			_z2024/05/07 15:23
501			_aAvailable online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
520			_aHypertension 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			_aEnglish
650			_a*Blood Pressure
650			_a*Device Approval
650			_a*Hypertension
650			_a*Renal Artery
650			_a*Sympathectomy
650			_a*United States Food and Drug Administration
650			_aAdvisory Committees
650			_aEquipment Design
650			_aHumans
650			_aHypertension/pp [Physiopathology]
650			_aHypertension/su [Surgery]
650			_aKidney/bs [Blood Supply]
650			_aRenal Artery/dg [Diagnostic Imaging]
650			_aRenal Artery/ir [Innervation]
650			_aRisk Factors
650			_aSympathectomy/ae [Adverse Effects]
650			_aSympathectomy/is [Instrumentation]
650			_aTreatment Outcome
650			_aUnited States
650			_zAutomated
651			_aMedStar Heart & Vascular Institute
651			_aMedStar Washington Hospital Center
656			_aAdvanced Cardiac Catheterization Research Fellowship R
656			_aInterventional Cardiology Fellowship
657			_aJournal Article
657			_aReview
700			_aChitturi, Kalyan _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dDO
700			_aHaberman, Dan _bMWHC _cInterventional Cardiology Fellowship _dMD
700			_aLupu, Lior _bMWHC _cInterventional Cardiology Fellowship _dMBA, MD
700			_aWaksman, Ron _bMHVI
700			_aWermers, Jason P _bMHVI
790			_aHaberman D, Chitturi KR, Lupu L, Wermers JP, Waksman R
856			_uhttps://dx.doi.org/10.1002/ccd.31065 _zhttps://dx.doi.org/10.1002/ccd.31065
858			_yWaksman, Ron _uhttp://orcid.org/0000-0002-4063-9226 _zhttp://orcid.org/0000-0002-4063-9226
942			_cART _dArticle
999			_c14547 _d14547