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Investing.com -- Boston Scientific (NYSE:BSX) stock fell 1.8% after the U.S. Food and Drug Administration (FDA) disclosed a potentially high-risk issue with the company’s defibrillation leads that has been linked to patient deaths.
The FDA announced it is aware that Boston Scientific has notified customers about certain ENDOTAK RELIANCE Defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils that may impact shock efficacy and/or require early replacement. The communication is part of the FDA’s Communications Pilot to Enhance the Medical (TASE:BLWV) Device Recall Program.
According to the FDA notice, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue as of July 24. The most common harm is early lead replacement, while the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from reduced shock energy due to high impedance.
The issue affects multiple models of ENDOTAK RELIANCE, RELIANCE 4-SITE, and RELIANCE 4-FRONT defibrillation leads. Boston Scientific has sent letters to healthcare providers recommending continued routine follow-up of defibrillation systems with ePTFE leads either via in-person or remote monitoring.
The company’s investigation found that calcification of the shock coil(s) does not compromise the physical or electrical integrity of the lead, but a trend of gradually rising low-voltage shock impedance (LVSI) is correlated with shock coil calcification. This trend is more prevalent with Boston Scientific’s RELIANCE ePTFE defibrillation leads compared to non-ePTFE defibrillation leads.
The FDA stated it is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
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