Boston Scientific Reports 16 Deaths Linked To Defibrillator Lead Issue

The Food and Drug Administration (FDA) said on Wednesday it is monitoring a potential safety issue involving Boston Scientific Corporation’s (NYSE:BSX) ENDOTAK RELIANCE defibrillation leads, following a letter from the company alerting healthcare providers of possible reduced shock efficacy.

Boston Scientific’s ENDOTAK RELIANCE leads are used with implantable cardioverter-defibrillators (ICDs) to deliver pacing and shock therapy to prevent sudden cardiac death.

The affected leads are coated with expanded polytetrafluoroethylene (ePTFE), which the company has linked to issues that could lead to early device replacement and, in severe cases, patient death.

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Boston Scientific alerted healthcare providers ...