Loftus Christopher M, Hoffmann Michael, Heetderks William, Zheng Xiaolin, Peña Carlos
Division of Neurological and Physical Medicine Devices (DNPMD), Center for Devices and Radiological Health (CDRH), United States Food and Drug Administration (FDA), Silver Spring, MD, United States.
Front Neurol. 2018 Jun 11;9:320. doi: 10.3389/fneur.2018.00320. eCollection 2018.
The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is charged with ensuring patients in the US have timely access to high-quality, safe, and effective medical devices of public health importance. Within CDRH, the Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the central and peripheral nervous system (neurotechnologies), including neurointerventional medical devices that are used in the treatment of stroke. Endovascular treatments have demonstrated recent advances in reaching the marketplace and providing more options for patients with acute ischemic stroke and intracranial aneurysms specifically. Depending upon the pathway chosen for regulatory approval, and the evidentiary standard for different regulatory pathways, neurotechnologies can have well-established safety and effectiveness profiles, varying degrees of scientific and clinical uncertainty regarding safety and effectiveness, or when a humanitarian use exists, need only demonstrate a probable benefit and safety to the patient so potentially life-saving treatments can reach the marketplace. Reperfusion therapies have had specific advances in the treatment of stroke patients that originally had limited or no treatment options and for preventative treatments in providing care to patients with intracranial aneurysms to avoid potentially more catastrophic outcomes. Collaboration in multiple forums and environments will be important to continue to foster the neurointerventional technology sector and positively impact clinical medicine, from diagnosing and treating a neurological disorder, to potentially altering the progression of disease, and in many ways, contemporary approved devices have brought a new sense of hope and optimism that serious and otherwise disabling neurological diseases can be treated and in many cases cured with modern therapy. We present here the scope of FDA's regulatory landscape for neurological devices and neurointerventional endovascular approaches for acute ischemic stroke; this is essential information for those seeking to successfully translate medical device neurotechnologies for patient and consumer use.
美国食品药品监督管理局（FDA）设备与放射健康中心（CDRH）负责确保美国患者能够及时获得对公众健康具有重要意义的高质量、安全且有效的医疗设备。在CDRH内部，神经与物理医学设备司负责审查与中枢和外周神经系统相互作用的医疗技术（神经技术），包括用于治疗中风的神经介入医疗设备。血管内治疗在进入市场方面取得了最新进展，尤其为急性缺血性中风和颅内动脉瘤患者提供了更多选择。根据选择的监管审批途径以及不同监管途径的证据标准，神经技术可能具有已确立的安全性和有效性概况，在安全性和有效性方面存在不同程度的科学和临床不确定性，或者在存在人道主义用途的情况下，只需证明对患者可能有益且安全，以便潜在的挽救生命的治疗方法能够进入市场。再灌注疗法在治疗最初治疗选择有限或没有治疗选择的中风患者以及为颅内动脉瘤患者提供预防治疗以避免潜在更灾难性后果方面取得了特定进展。在多个论坛和环境中开展合作对于继续促进神经介入技术领域发展并对临床医学产生积极影响至关重要，从诊断和治疗神经系统疾病到潜在改变疾病进程，而且在很多方面，当代获批的设备带来了新的希望和乐观情绪，即严重且致残的神经系统疾病可以通过现代疗法进行治疗，并且在许多情况下可以治愈。我们在此介绍FDA对神经设备和急性缺血性中风的神经介入血管内治疗方法的监管范围；这对于那些寻求成功将医疗设备神经技术转化为患者和消费者用途的人来说是至关重要的信息。
