Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system.

Autor: Lupu L; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC., Haberman D; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC., Chitturi KR; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC., Wermers JP; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC., Ben-Dor I; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC., Waksman R; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 Sep; Vol. 275, pp. 21-34. Date of Electronic Publication: 2024 May 29.
DOI: 10.1016/j.ahj.2024.05.011
Abstrakt: Tricuspid 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.
Competing Interests: Declarations of Competing Interest Kalyan R. Chitturi – Consultant: Glass Health. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. All other authors – None.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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