Update on a new subgroup 3 and failure rates for HeartWare™ Ventricular Assist Device (HVAD™) System
Medtronic International Limited has issued a new communication directed towards healthcare professionals. This letter serves as a continuation of their previous correspondences in January 2021, July 2021, March 2022, and October 2022.
The purpose of this communication is to provide healthcare professionals with important information regarding the following:
a) Identification of an additional subgroup known as subgroup 3, which may have a higher likelihood of experiencing delays or failures in restarting the HeartWare™ Ventricular Assist Device (HVAD™) compared to the general HVAD™ population.
b) The current failure rates associated with events involving the failure or delay in restarting the pump.
c) Reiteration of the existing patient management recommendations, which are also applicable to subgroup 3.
Healthcare professionals are strongly advised to adhere to the patient management recommendations provided and to develop tailored care plans for patients falling within subgroup 3.
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/update-on-a-new-subgroup-3-and-failure-rates-for-heartware-ventricular-assist-device-(hvad)-system
Link to the FDA announcement: https://www.fda.gov/medical-devices/cardiovascular-devices/medtronic-heartware-ventricular-assist-device-hvad-system
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