ACTION Centers Collaborate With Johnson & Johnson MedTech to Secure FDA Labeling for Impella Support System in Pediatric Patients
ACTION Centers Collaborate With Johnson & Johnson MedTech to Secure FDA Labeling for Impella Support System in Pediatric Patients
The collaboration between ACTION and Johnson & Johnson MedTech includes not only evidence generation but also the development of pediatric-focused educational materials about heart failure. These resources will be available on the ACTION education site, MyACTIONEducation.org, featuring engaging animations, infographics, and articles designed to help children, parents, and caregivers better understand heart failure and explore their treatment options.CINCINNATI, Dec. 13, 2024 /PRNewswire/ -- In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech's Impella Support System to include treatment for certain children suffering from heart failure, extending the original approval for care of adults with heart failure. This significant advancement is the result of a collaboration between Johnson & Johnson MedTech and ACTION (Advanced Cardiac Therapies Improving Outcomes Network), a network of over 60 medical institutions. The collaboration is aimed at building real-world, adjudicated data to support FDA approvals.
辛辛那提，2024年12月13日 /PRNewswire/ — 美国食品药品管理局扩大了强生医疗科技Impella支持系统的标签，将某些患有心力衰竭的儿童的治疗包括在内，从而延长了最初对成人心力衰竭护理的批准，这是儿科心脏护理领域的开创性成就。这一重大进展是强生医疗科技与ACTION（先进心脏疗法改善疗效网络）合作的结果，ACTION是一个由60多家医疗机构组成的网络。此次合作旨在建立真实的裁决数据，以支持 FDA 的批准。
Previously, the Impella Support System was approved for use in adults. ACTION's clinical providers not only gathered essential foundational data but also enhanced clinical understanding of ventricular assist devices (VADs) for pediatric use. Families, caregivers, and medical providers can now benefit from improved access to this life-saving technology.
以前，Impella 支持系统已获准用于成人。ACTION的临床提供者不仅收集了重要的基础数据，而且增强了对儿科用心室辅助设备（VAD）的临床理解。现在，家庭、护理人员和医疗服务提供者可以从改善获得这种救生技术的机会中受益。
"This announcement marks a monumental achievement for children with heart failure," said Angela Lorts, MD, MBA, and David Rosenthal, MD, Co-Founders of ACTION. "Historically, this area of care has been underfunded and understudied in pediatrics. The approval of the Impella Support System for children with heart failure represents an enormous leap forward in improving heart failure outcomes for children. We are proud to have collaborated with Abiomed on this crucial FDA process and look forward to further partnerships that will enhance care for these vulnerable patients."
“这一宣布标志着心力衰竭儿童取得的巨大成就，” 医学博士、工商管理硕士安吉拉·洛茨和ACTION联合创始人大卫·罗森塔尔医学博士说。“从历史上看，这一护理领域的资金不足，儿科研究不足。针对心力衰竭儿童的Impella支持系统的批准是在改善儿童心力衰竭预后方面向前迈出的巨大飞跃。我们很自豪能够与Abiomed就这一关键的FDA流程进行合作，并期待进一步的合作伙伴关系，以加强对这些弱势患者的护理。”
The collaboration between ACTION and Johnson & Johnson MedTech includes not only evidence generation but also the development of pediatric-focused educational materials about heart failure. These resources will be available on the ACTION education site, MyACTIONEducation.org, featuring engaging animations, infographics, and articles designed to help children, parents, and caregivers better understand heart failure and explore their treatment options.
ACTION与强生医疗科技之间的合作不仅包括证据生成，还包括开发以儿科为重点的心力衰竭教育材料。这些资源将在行动教育网站MyActionEducation.org上提供，其中包括引人入胜的动画、信息图表和文章，旨在帮助儿童、父母和看护人更好地了解心力衰竭并探索他们的治疗方案。
ACTION and Johnson & Johnson MedTech are paving the way for innovative therapies, offering renewed hope to thousands of children living with heart failure and their families.
ACTION和强生医疗科技正在为创新疗法铺平道路，为成千上万的心力衰竭儿童及其家庭带来了新的希望。
See the press release issued by Johnson & Johnson MedTech.
参见强生医疗科技公司发布的新闻稿。
MEDIA CONTACT
On behalf of ACTION
Phillip Sontag
917.446.4123
[email protected]
媒体联系人
代表 ACTION
菲利普·桑塔格
917.446.4123
[电子邮件保护]
SOURCE ACTION
源动作