大家知道，以往往各厂家生产的起博器（Pacemakers）在患者接受磁共振成像检查的过程中并不能够保障其功能正常，这也是为何临床医生常常避免给被安装起搏器的患者行磁共振成像检查的原因。事实上，约有一半被安装起搏器的患者因故需要进行磁共振成像检查。因此，研发可在磁共振成像检查过程中正常工作的起搏器就成了各商家竞相追逐的热点。日前有报道，美国食品药品管理局（The U.S. Food and Drug Administration，FDA）已经批准了第一款可供磁共振成像检查过程中安全使用的人工起搏器，后者全称为The Revo MRI SureScan Pacing System。该系统的成功问世无疑对需要安装起搏器的患者而言是一个好消息，是一大福音！

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  magnetic and radiofrequency fields can disrupt the pacemaker 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 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 approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA 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.