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.
