Ventricular Assist Device | 合法醫療器材資訊網

MedtronichasstoppedthedistributionandsaleoftheHVAD™SystemasofJune3,2021,andhasnotifiedphysicianstoceasenewimplantsoftheMedtronic​ ...

Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021 and has notified physicians to cease new implants of the HVAD System and transition to an alternative commercially available left ventricular assist devices (LVAD) for all future implants. Replacement of the HVAD System is not recommended at this time for patients who currently have the device because, in the vast majority of cases, the risks associated with additional surgery outweighs the benefit of a replacement device. If you have questions about this, please contact your healthcare provider.

Medtronic initiated this action in light of a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD™ System as compared to other commer...