Overview of the FDA's Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart - portable extracorporeal heart perfusion and monitoring system. [Review] Overview of the FDA's Virtual Circulatory System Devices Advisory Panel on the TransMedics Organ Care System (OCSTM) Heart - Portable Extracorporeal Heart Perfusion and Monitoring System.

MedStar author(s):
Citation: American Heart Journal. 247:90-99, 2022 May.PMID: 35150637Institution: MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Interventional Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Heart Transplantation | Heart | Heart Transplantation/mt [Methods] | Humans | Perfusion/mt [Methods] | Tissue Donors | United States | United States Food and Drug AdministrationYear: 2022Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006Name of journal: American heart journalAbstract: There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCSTM) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration (FDA) convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCSTM Heart System's application for premarket approval (PMA). This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented. Copyright (c) 2022 Elsevier Ltd. All rights reserved.All authors: Case BC, Molina EJ, Pahuja M, Waksman ROriginally published: American Heart Journal. 2022 Feb 09Fiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-02-22
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 35150637 Available 35150637

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCSTM) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration (FDA) convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCSTM Heart System's application for premarket approval (PMA). This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented. Copyright (c) 2022 Elsevier Ltd. All rights reserved.

English

Powered by Koha