U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
"This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied," said Impella 5.5 and Impella CP are the first left-sided, minimally invasive temporary mechanical circulatory support options for pediatric patients with symptomatic ADHF and cardiogenic shock
Impella 5.5 和 Impella CP 是首批左侧、微创的临时机械循环支持选项，适用于有症状注意力缺陷多动症和心源性休克的儿科患者
DANVERS, Mass., Dec. 12, 2024 /PRNewswire/ -- Physicians have a new treatment option for many of the sickest pediatric patients with heart failure and cardiogenic shock. Johnson & Johnson MedTech, the global leader in heart recovery, announced today that the U.S. Food and Drug Administration (FDA) has expanded the indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, granting premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. A PMA is the highest level of approval granted by the FDA for the safety and efficacy of medical devices.
马萨诸塞州丹弗斯，2024年12月12日 /PRNewswire/ — 对于许多病情最严重的心力衰竭和心源性休克的儿科患者，医生有了新的治疗选择。心脏康复领域的全球领导者强生医疗科技今天宣布，美国食品药品监督管理局（FDA）已扩大了带SmartAssist的Impella 5.5和带SmartAssist心脏泵的Impella CP的适应症，批准了上市前批准（PMA），用于有症状的急性失代偿性心力衰竭（ADHF）和心源性休克的特定儿科患者。PMA 是 FDA 授予医疗器械安全性和有效性的最高批准级别。
Impella 5.5 and Impella CP enable heart recovery as part of the world's smallest heart pump platform. Johnson & Johnson MedTech (Abiomed, Inc.) has partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION)1 to provide the real-world data necessary to support on-label use of Impella 5.5 and Impella CP, both left-sided heart pumps, for pediatric patients with symptomatic ADHF and cardiogenic shock. ACTION is a global healthcare network comprised of patients, families, clinicians, researchers and industry representatives that collaborate with ACTION leadership to improve outcomes for patients.
作为世界上最小的心脏泵平台的一部分，Impella 5.5 和 Impella CP 可实现心脏恢复。强生医疗科技（Abiomed，Inc.）已与高级心脏疗法改善疗效网络（ACTION）1合作，为有症状注意力缺陷多动症和心源性休克的儿科患者提供必要的真实数据，以支持在标签上使用Impella 5.5和Impella CP（均为左侧心脏泵）。ACTION是一个由患者、家属、临床医生、研究人员和行业代表组成的全球医疗保健网络，他们与ACTION领导层合作，改善患者的预后。
"This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied," said Angela Lorts, MD, MBA2, and David Rosenthal, MD, Co-Founders of ACTION. "We are proud to have worked with Johnson & Johnson MedTech on this crucial approval and look forward to further collaborations that will enhance care for these vulnerable patients."
MBA2医学博士安吉拉·洛茨和ACTION联合创始人大卫·罗森塔尔说：“这标志着心力衰竭儿童取得的巨大成就，因为从历史上看，这一儿科护理领域的资金不足和研究不足。”“我们很自豪能与强生医疗科技公司合作获得这项重要批准，并期待进一步的合作，以加强对这些弱势患者的护理。”
Impella CP and Impella 5.5 heart pumps unload the heart's left ventricle, allowing the heart to rest while also ensuring delivery of oxygenated blood throughout the body. The PMA amendment expands the usage of left-sided Impella devices to specific pediatric patients weighing ≥52kg for Impella CP and ≥30kg for Impella 5.5.
Impella CP 和 Impella 5.5 心脏泵可卸下心脏的左心室，让心脏休息，同时还能确保充氧血液输送到全身。PMA修正案将左侧Impella设备的使用范围扩大到特定儿科患者，Impella CP体重≥52kg，Impella 5.5体重≥30kg。
"The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude," said Sonya Bhavsar, PhD, Senior Director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech. "This milestone motivates us to continue innovating solutions to increase the number of life years that these patients have and can spend with their families and loved ones."
强生医疗科技心脏康复ECP和儿科平台研发高级董事索尼娅·巴夫萨尔博士说：“利用我们的生命支持技术治疗儿科患者的心脏的机会令人难以置信，也让我们充满感激之情。”“这一里程碑激励我们继续创新解决方案，以延长这些患者的生命年限，并且可以与家人和亲人共度时光。”
A dedicated team will develop and refine training and education programs designed specifically for pediatric patients alongside these patients' doctors. In collaboration with ACTION and previously identified hospitals, these tools and resources will be optimized to help improve outcomes and the quality of life for these pediatric patients. This strategic approach will equip the best-in-class heart recovery field team and providers with the skills to best support these patients now and in the future.
一个专门的团队将与这些患者的医生一起制定和完善专门为儿科患者设计的培训和教育计划。将与ACTION和先前确定的医院合作，优化这些工具和资源，以帮助改善这些儿科患者的预后和生活质量。这种战略方针将使一流的心脏康复现场团队和提供者具备在现在和将来为这些患者提供最佳支持的技能。
The FDA indication for use of Impella CP with SmartAssist has been expanded as follows:
美国食品药品管理局关于使用带有 SmartAssist 的 Impella CP 的指令已扩展如下：
The Impella CP with SmartAssist Catheter, in conjunction with the Automated Impella Controller (collectively, "Impella System Therapy"), are temporary ventricular support devices intended for short term use (≤4 days) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP) in adult patients and in pediatric patients weighing ≥52 kg. The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
带有 SmartAssist 导管的 Impella CP 与自动脉冲控制器（统称为 “Impella 系统疗法”）配合使用，是短期使用（≤4 天）的临时心室支持设备，适用于治疗急性心肌梗塞或心脏直视手术后立即发生（
The FDA indication for use of Impella 5.5 with SmartAssist has been expanded as follows:
美国食品药品管理局关于使用带有 SmartAssist 的 Impella 5.5 的指示已扩展如下：
The Impella 5.5 with SmartAssist System is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP) in adult patients and in pediatric patients weighing ≥30 kg. The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
带有 SmartAssist System 的 Impella 5.5 是一种临时心室支持设备，适用于短期（14 天）使用，适用于治疗急性心肌梗塞或心脏直视手术后立即发生的持续心源性休克，或发生在心肌病（包括围产期心肌病）或由于孤立性左心衰竭引起的心肌炎，即对最佳的医疗管理和常规治疗措施（包括体积负荷和使用压力器和内向剂）没有反应，或不使用 IABP）适用于成年患者和体重≥30 kg的儿科患者。Impella System Therapy的目的是减少心室工作，提供必要的循环支持，以使心脏恢复和早期评估残留的心肌功能。
Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information about heart recovery technology, visit .
强生医疗科技的心血管解决方案
在强生公司，我们正在应对世界上最复杂和最普遍的健康挑战。通过为医疗保健专业人员提供先进的测绘和导航、微型化技术和精确消融术的心血管产品组合，我们正在解决心力衰竭、冠状动脉疾病、中风和心房颤动等需求未得到满足的严重疾病。我们是心脏恢复、循环恢复和心律失常治疗领域的全球领导者，也是神经血管护理领域的新兴领导者，致力于解决全球心力衰竭和中风这两个主要死因。有关心脏恢复技术的更多信息，请访问。
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at @JNJMedTech and on LinkedIn. Abiomed, Inc. is part of Johnson & Johnson MedTech.
关于强生
在强生，我们相信健康就是一切。我们在医疗创新方面的实力使我们能够建立一个可以预防、治疗和治愈复杂疾病、治疗更智能、侵入性更小、解决方案个性化的世界。凭借我们在创新医学和医疗技术方面的专业知识，我们在当今的全方位医疗解决方案中处于独特的地位，能够实现未来的突破，并对人类的健康产生深远影响。要详细了解我们的医疗科技行业的全球规模以及在心血管、骨科、手术和视觉解决方案方面的深厚专业知识，请访问。通过 @JNJMedTech 和 LinkedIn 关注我们。Abiomed, Inc. 是强生医疗科技的一部分。
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the Impella Platform. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Abiomed, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. Neither Abiomed, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments
有关前瞻性陈述的注意事项
本新闻稿包含1995年《私人证券诉讼改革法》中有关Impella平台的 “前瞻性陈述”。这些陈述基于当前对未来事件的预期。如果基本假设证明存在不准确或已知或未知的风险或不确定性，则实际结果可能与Abiomed, Inc.和/或强生公司的预期和预测存在重大差异。风险和不确定性包括但不限于：监管批准的不确定性；商业成功的不确定性；专利挑战；竞争，包括技术进步、新产品和竞争对手获得的专利；导致产品召回或监管行动的产品功效或安全问题；适用法律和法规的变化，包括全球医疗改革；医疗保健产品和服务购买者的行为和支出模式的变化；以及医疗保健成本控制的趋势。这些风险、不确定性和其他因素的更多清单和描述可以在强生截至2023年12月31日财年的10-k表年度报告中找到，包括标题为 “关于前瞻性陈述的警示说明” 和 “第1A项” 的章节。风险因素”，以及强生公司随后向美国证券交易委员会提交的10-Q表季度报告和其他文件中。这些文件的副本可在sec.gov、jnj.com上在线获得，或应强生公司的要求提供。Abiomed, Inc. 和强生公司均未承诺根据新信息或未来事件或事态发展更新任何前瞻性陈述
1Cincinnati Children's Hospital Medical Center (CHMC) is the coordinating center for the research and health care quality improvement efforts of Advanced Cardiac Therapies Outcome Network (ACTON). Funding for this ACTION research program was provided by Abiomed, Inc. to CHMC.
2Angela Lorts, MD, MBA was compensated for her role as principal Investigator on this research program.
1辛辛那提儿童医院医疗中心（CHMC）是高级心脏疗法结果网络（ACTON）研究和医疗保健质量改进工作的协调中心。这项行动研究计划的资金由Abiomed, Inc.提供给CHMC。
2Angela Lorts，医学博士，工商管理硕士，因担任该研究项目的首席研究员而获得报酬。
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SOURCE Johnson & Johnson MedTech
来源：强生医疗科技
