ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).

伊利诺伊州阿灵顿高地（商业新闻短讯）--GE HealthCare（纳斯达克：GEHC）今天宣布，美国食品和药物管理局（FDA）已批准Flyrcado™（氟哌啶F 18）注射液，这是第一种正电子发射断层扫描心肌灌注成像（PET MPI）试剂，用于检测冠状动脉疾病（CAD）。

Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women1..

Flyrcado 适用于已知或疑似 CAD 患者，与当今核心脏病学中常用的单光子发射计算机断层扫描 （SPECT） MPI 相比，Flyrcado 具有更高的诊断效力。Flyrcado可以在场外药房生产，并以即用型单位剂量提供，有可能扩大临床医生和患者获得PET MPI的机会，包括提高难以成像的患者（如体重指数（BMI）高的患者和女性）的诊断准确性1..

With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients.

Flyrcado的半衰期比现有的PET MPI示踪剂长109分钟，因此不需要现场示踪剂生产和发生器维护，并能够分发到广泛的医院和成像中心网络。这种更长的半衰期也意味着Flyrcado带来了第一个将运动压力测试与心脏PET成像结合用于CAD的实际机会，从而为评估患者缺血提供了最可靠的方案。

Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan..

此外，如果出现技术困难，临床医生将能够在同一成像过程中重新扫描患者，而不是重新安排额外的扫描。。

Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades.

Jamshid Maddahi博士，医学博士，FACC，MASNC，Flyrcado临床试验首席研究员，加州大学洛杉矶分校医学院医学（心脏病学）和分子与医学药理学（核医学）临床教授，生物医学成像研究所所长，说：“Flyrcado是过去几十年来核心脏病学领域最令人兴奋的发展。

Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI2, only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.”.

尽管与SPECT MPI2相比，PET MPI作为一种模式能够实现较高的诊断准确性，但在美国，只有少数年度PET扫描是PET MPI，因为目前可用的PET示踪剂的使用有限，这可能会通过引入Flyrcado来解决。我对这种新的放射性示踪剂及其潜在影响感到兴奋，因为它改变了游戏规则，能够诊断出世界上死亡率最高的疾病。”。

CAD is the most common form of heart disease and remains the leading cause of death for men and women in the U.S.3, with 695,000 deaths recorded in 20214. During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI.

冠心病是最常见的心脏病形式，仍然是美国男性和女性的主要死亡原因3，20214年有695000人死亡。在多中心国际AURORA III期临床试验中，将氟哌吡嗪F 18与有创冠状动脉造影进行比较，作为判断冠心病诊断效果的真实标准，并与SPECT MPI进行比较。

Around six million MPI procedures are undertaken each year in the U.S.5 to show blood flow through the heart muscle, and evaluate the presence, extent and degree of myocardial ischemia or infarction..

在美国，每年大约进行 600 万例 MPI 手术5，以显示流经心肌的血流，并评估心肌缺血或梗塞的存在、范围和程度。

Dr. Mouaz Al-Mallah, MD, MSc, MASNC, immediate Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, said “Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients.

美国核心脏病学会（ASNC）前任主席、休斯顿卫理公会医院心脏PET主任、医学博士、理学硕士Mouaz Al-Mallah博士表示，“鉴于氟哌啶F 18在心肌摄取和氟-18成像特征方面的理想特性，Flyrcado代表了成像剂药理学和成像机构和患者便利性的良好组合。

There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients.”.

这种示踪剂可以实现心脏PET的新前沿；它可以作为单位剂量订购，并且可以灵活地进行运动压力测试。我们期望新的成像中心能够为患者提供心脏PET，从而更方便地获取PET MPI，并为临床医生及其患者提供有意义的影响。”。

Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.”.

GE HealthCare 药物诊断 （PDx） 部门首席执行官 Kevin O'Neill 表示：“作为第一个也是唯一一个获得 FDA 批准的用于 CAD 检测的 F 18 PET MPI 放射性示踪剂，Flyrcado 可以为临床医生及其患者带来真正的改变。这是 GE HealthCare 致力于创新和投资以塑造分子成像的未来、提高诊断信心并解决未满足的患者需求的又一个例子。

Flyrcado is one of three F 18 imaging agents in GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, joining radiopharmaceutical PET imaging agents Cerianna™ (fluoroestradiol F 18) injection, used to detect estrogen receptor positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer, and Vizamyl™ (flutemetamol F 18) injection which is a PET tracer for imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline..

Flyrcado是GE HealthCare FDA批准的分子成像PET产品组合中的三种F 18成像剂之一，加入放射性药物PET成像剂Cerianna™（氟雌二醇F 18）注射液，用于检测雌激素受体阳性病变，作为转移性和复发性乳腺癌患者活检的辅助手段，以及Vizamyl™（flutemetamol F 18）注射液，它是一种PET示踪剂，用于大脑成像，以估计正在评估阿尔茨海默病或其他认知能力下降原因的成年患者的β-淀粉样神经炎斑块密度。。

GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and has led the funding and development of the product through to approval. Lantheus collaborated on the development and will also collaborate on commercialization through a joint steering committee.

2017年，GE HealthCare从Lantheus获得了氟哌啶F 18的独家全球商业化权利，并领导了该产品的资助和开发，直至获得批准。Lantheus在开发方面进行了合作，并将通过联合指导委员会在商业化方面进行合作。

Lantheus is entitled to royalties based on commercial sales milestones..

Lantheus有权根据商业销售里程碑收取版税。。

Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter.

Flyrcado将于2025年初在最初的美国市场上市，此后将扩大上市范围。

As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second..

作为全球领先的医疗技术和药物诊断创新者，GE HealthCare提供分子成像设备和用于心脏病学、神经病学和肿瘤学的专有放射性药物。PDx部门是成像剂领域的全球领导者，全球每年用于支持超过1.2亿例患者手术，相当于每秒四例患者手术。。

About GE HealthCare Technologies Inc.

关于GE HealthCare Technologies Inc。

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier.

GE HealthCare是全球领先的医疗技术、药物诊断和数字解决方案创新者，致力于提供集成的解决方案、服务和数据分析，使医院更高效、临床医生更有效、治疗更精确，患者更健康、更快乐。

Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring.

GE HealthCare为患者和提供者服务了125多年，正在推进个性化、互联化和富有同情心的护理，同时简化患者跨越护理路径的旅程。我们的成像、超声波、患者护理解决方案和药物诊断业务共同帮助改善患者护理，从诊断到治疗再到监测。

We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits..

我们是一家价值196亿美元的企业，拥有约51000名员工，致力于创造一个医疗保健无限的世界。。