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【科普】美国FDA批准首个可在MRI中安全工作的心
2011年2月8日，美国食品与药物管理局（FDA）发布公告,批准首个设计可在某些核磁共振成像（MRI）检查中安全使用的心脏起搏器。
心脏起搏器是用手术方法置入的医疗器械，可产生电脉冲，用于治疗心脏不规则跳动或心跳停顿。MRI检查使用强大的磁场、射频脉冲和一台内置计算机，以生成用其他成像方法不能得到的器官、软组织、骨骼和其他人体内部结构的详细图像。
约半数带有心脏起搏器的患者可能需要接受MRI检查，但他们被告知不可进行MRI，因为MRI的磁场和射频场会干扰心脏起搏器的设置或引起电线过热，导致意外的心脏刺激、器械电故障或组织损害。
Revo MRI SureScan心脏起搏系统包含一个功能，这个功能在扫描之前被开启，为患者做好MRI的准备。心脏起搏器在MRI中的使用仅限于某些患者、身体的某些部位、以及某些扫描参数。FDA同时要求对使用该系统的心脏科和放射科医生进行培训。
“Revo心脏起搏器获得FDA批准，代表着向更大的设备更新迈出了重要一步”，FDA器械和辐射健康中心主任Jeffrey·Shuren博士说。“那些符合该器械参数的患者将能够维持其至关重要的心脏治疗，同时又可以从MRI的精确诊断能力中获益。”
FDA审核了1项纳入484例患者的临床试验结果。其中，464例患者被成功置入该器械，随后随机接受或者不接受MRI检查。在211例接受MRI检查的患者中，无1例出现与MRI有关的并发症。该临床结果证实了来自动物实验、计算模型以及其他非临床研究的早期数据。 FDA NEWS RELEASE
For Immediate Release: Feb. 8, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves 1st pacemaker designed to work safely during some MRI exams
The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.
Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.
About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI’s magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.
“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.”
The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.
Revo is manufactured by Medtronic Inc. of Mounds View, Minn. [标签:content2]
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作者:admin@医学,生命科学 2011-02-10 23:38
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