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波士顿科学起搏器可能需要早期更换：FDA
2024-12-17 01:19
- The U.S. FDA on Monday said that a line of Boston Scientific (NYSE:BSX) pacemakers may need early replacement.
- The agency's communication follows a company urgent device notification this month regarding a subset of its Accolade pacemakers, noting the issue is related to the devices potentially entering safety mode due to high battery impedance. This can lead to an inability to regulate heart rate correctly.
- Boston Scientific said it is aware of two deaths following the pacemakers entering safety mode.
- The FDA said that doctors should work with patients who have the potentially impacted pacemakers to look into remote monitoring of the device or have patients come in regularly to have the devices checked.
- The agency added that if monitoring indicates the pacemaker enters safety mode unexpectedly, it should be replaced.
- Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers, as well as the Visionist and Valitude cardiac resynchronization therapy pacemakers, are impacted by the notificaiton.
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