雅培获得FDA批准的MR条件标签的安全起搏器

Abbott, St. Jude Medical, FDA approval, MR-conditional labeling, Assurity pacemaker, Tendril pacing leadFDA还批准了Tendril MRI起搏导线的MR条件标记

2017年2月2日 – 雅培宣布美国食品和药物管理局(FDA)批准磁共振(MR)条件标签,用于Assurity MRI起搏器和Tendril MRI起搏导线。如果需要,植入这些低电压装置的患者将具有进行全身磁共振成像(MRI)扫描的能力。获得批准后,根据雅培,Assurity MRI起搏器现在是世界上最小,最长的无线MRI兼容起搏器。

tendril-mri-rfenergy-infographic

Assurity MRI起搏器由St. Jude Medical开发,今年1月初被Abbott收购。

Assurity MRI起搏器还提供无线远程监控,为医生提供安全访问其患者诊断数据和每日设备测量的能力,并减少对办公室访问的需求。对心脏病患者的远程监测已经成为过去十年的最佳实践,并且研究继续证明其对患者结果和减少医疗保健成本的积极影响。 2015年,心律学会在其指南中制定了无线远程监控标准的护理。

允许患者进行MRI扫描的起搏器,如Assurity MRI起搏器,已经成为未来可能需要MRI但不希望对其植入物造成损害的患者的重要进步。在MRI扫描期间,Assurity MRI起搏器与雅培的MRI Activator手持设备配合使用,以针对个别患者触发预编程的MRI设置。这种技术可以帮助消除通常与常规扫描前和扫描后起搏器重编程相关的努力,时间和病人不便。

Oklahoma心脏研究所电气生理学主任David Sandler博士说:“一个持久,小型的无线起搏器允许患者进行MRI扫描,这是向患者提供可用的治疗选择的重要一步。 “选择最能满足患者心脏状况的设备的能力不再与MRI兼容性相悖,这是两个领域中最好的。

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以上内容由Google翻译而来,原文如下:

Abbott Receives FDA Approval for MR-Conditional Labeling of Assurity Pacemaker

FDA also approves MR-conditional labeling for Tendril MRI pacing lead

February 2, 2017 — Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for both the Assurity MRI pacemaker and the Tendril MRI pacing lead. Patients implanted with these low-voltage devices will have the ability to undergo full body magnetic resonance imaging (MRI) scans, if required. With the approval, the Assurity MRI pacemaker is now the world’s smallest, longest-lasting wireless MRI-compatible pacemaker, according to Abbott.

The Assurity MRI pacemaker was developed by St. Jude Medical, which was acquired by Abbott in early January of this year.

The Assurity MRI pacemaker also offers wireless remote monitoring, providing physicians secure access to their patients’ diagnostic data and daily device measurements and reducing the need for in-office visits. Remote monitoring of cardiac patients has become a best practice over the past decade, and studies have continued to prove its positive impact on patient outcomes and the reduction of healthcare costs. In 2015, the Heart Rhythm Society made wireless remote monitoring the standard of care in its guidelines.

Pacemakers that allow patients to undergo MRI scans, such as the Assurity MRI pacemaker, have become an important advancement for patients who may need an MRI in the future but who do not want to risk damage to their implant. During an MRI scan, the Assurity MRI pacemaker works with Abbott’s MRI Activator handheld device to trigger pre-programmed MRI settings appropriately tailored to individual patients. This technology can help eliminate the effort, time and patient inconvenience commonly associated with conventional pre- and post-scan pacemaker reprogramming.

“A long-lasting and small wireless pacemaker that allows patients to undergo MRI scans is an important step forward in growing our available treatment options for patients,” said David Sandler, M.D., director of electrophysiology at the Oklahoma Heart Institute in Tulsa, Okla. “The ability to choose a device to best address a patient’s cardiac condition no longer has a tradeoff with MRI compatibility. It’s the best of both worlds.”

For more information: www.sjm.com