000			02892nam a22004577a 4500
008			240807s20242024 xxu||||| |||| 00| 0 eng d
022			_a0002-8703
024			_aS0002-8703(24)00126-1 [pii]
040			_aOvid MEDLINE(R)
099			_a38815781
245			_aOverview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system.
251			_aAmerican Heart Journal. 275:21-34, 2024 May 29.
252			_aAm Heart J. 275:21-34, 2024 May 29.
253			_aAmerican heart journal
260			_c2024
260			_fFY2024
260			_p2024 May 29
265			_saheadofprint
265			_tPublisher
266			_d2024-08-07
266			_z2024/05/30 19:21
501			_aAvailable online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
520			_aTricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting. Copyright © 2024 Elsevier Inc. All rights reserved.
546			_aEnglish
650			_aIN PROCESS -- NOT YET INDEXED
650			_zAutomated
651			_aMedStar Heart & Vascular Institute
651			_aMedStar Washington Hospital Center
656			_aAdvanced Cardiac Catheterization Research Fellowship
656			_aInterventional Cardiology Fellowship
657			_aJournal Article
700			_aBen-Dor, Itsik _bMHVI
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			_aLupu L, Haberman D, Chitturi KR, Wermers JP, Ben-Dor I, Waksman R
856			_uhttps://dx.doi.org/10.1016/j.ahj.2024.05.011 _zhttps://dx.doi.org/10.1016/j.ahj.2024.05.011
942			_cART _dArticle
999			_c14387 _d14387