Deepa Mokshagundam MD , David N. Rosenthal MD , Lauren Smyth MHA , Angela Lorts MD, MBA
{"title":"Bridging gaps in pediatric device development: The power of ACTION – a collaborative learning network","authors":"Deepa Mokshagundam MD , David N. Rosenthal MD , Lauren Smyth MHA , Angela Lorts MD, MBA","doi":"10.1016/j.healun.2024.12.018","DOIUrl":null,"url":null,"abstract":"<div><div>Progress in the field of pediatric ventricular assist devices (VAD) have revolutionized the care and management of young patients with end-stage heart failure. However, innovation in pediatric medical devices is limited by financial and regulatory barriers due to the small and heterogenous target population. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) was established in 2017 as a learning network to improve outcomes of pediatric patients supported on VAD. Here we describe how intentional design of the ACTION registry has mitigated regulatory and financial barriers to pediatric VAD innovation through the use of real-world evidence gathered through a learning network.</div></div>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":"44 4","pages":"Pages 541-544"},"PeriodicalIF":6.4000,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Heart and Lung Transplantation","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1053249824020321","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Progress in the field of pediatric ventricular assist devices (VAD) have revolutionized the care and management of young patients with end-stage heart failure. However, innovation in pediatric medical devices is limited by financial and regulatory barriers due to the small and heterogenous target population. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) was established in 2017 as a learning network to improve outcomes of pediatric patients supported on VAD. Here we describe how intentional design of the ACTION registry has mitigated regulatory and financial barriers to pediatric VAD innovation through the use of real-world evidence gathered through a learning network.
期刊介绍：
The Journal of Heart and Lung Transplantation, the official publication of the International Society for Heart and Lung Transplantation, brings readers essential scholarly and timely information in the field of cardio-pulmonary transplantation, mechanical and biological support of the failing heart, advanced lung disease (including pulmonary vascular disease) and cell replacement therapy. Importantly, the journal also serves as a medium of communication of pre-clinical sciences in all these rapidly expanding areas.
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