FDA Alerts Health Care Providers to Stop New Implants of ... | 合法醫療器材資訊網

2021年6月3日—FDAisalertinghealthcareproviderstonolongerimplantend-stageheartfailurepatientswithMedtronic'sHeartwareVentricularAssist ...

For Immediate Release: June 03, 2021

The U.S. Food and Drug Administration is alerting[1] health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.

Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter[2] requesting physicians to stop new implants of the device. This action comes after the company received over 100 ...

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2021年6月3日 — FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic's Heartware Ventricular Assist ... Read More

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