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/ — 美國食品藥品管理局擴大了強生醫療科技Impella支持系統的標籤，將某些患有心力衰竭的兒童的治療包括在內，從而延長了最初對成人心力衰竭護理的批准，這是兒科心臟護理領域的開創性成就。這一重大進展是強生醫療科技與ACTION（先進心臟療法改善療效網絡）合作的結果，ACTION是一個由60多家醫療機構組成的網絡。此次合作旨在建立真實的裁決數據，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 支持系統已獲准用於成人。ACTION的臨床提供者不僅收集了重要的基礎數據，而且增強了對兒科用心室輔助設備（VAD）的臨床理解。現在，家庭、護理人員和醫療服務提供者可以從改善獲得這種救生技術的機會中受益。
"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."
「這一宣佈標誌着心力衰竭兒童取得的巨大成就，」 醫學博士、工商管理碩士安吉拉·洛茨和ACTION聯合創始人大衛·羅森塔爾醫學博士說。「從歷史上看，這一護理領域的資金不足，兒科研究不足。針對心力衰竭兒童的Impella支持系統的批准是在改善兒童心力衰竭預後方面向前邁出的巨大飛躍。我們很自豪能夠與Abiomed就這一關鍵的FDA流程進行合作，並期待進一步的合作伙伴關係，以加強對這些弱勢患者的護理。」
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與強生醫療科技之間的合作不僅包括證據生成，還包括開發以兒科爲重點的心力衰竭教育材料。這些資源將在行動教育網站MyActionEducation.org上提供，其中包括引人入勝的動畫、信息圖表和文章，旨在幫助兒童、父母和看護人更好地了解心力衰竭並探索他們的治療方案。
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和強生醫療科技正在爲創新療法鋪平道路，爲成千上萬的心力衰竭兒童及其家庭帶來了新的希望。
See the press release issued by Johnson & Johnson MedTech.
參見強生醫療科技公司發佈的新聞稿。
MEDIA CONTACT
On behalf of ACTION
Phillip Sontag
917.446.4123
[email protected]
媒體聯繫人
代表 ACTION
菲利普·桑塔格
917.446.4123
[電子郵件保護]
SOURCE ACTION
源動作
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