Medtronic's LVAD Pulled From Market Due to Neurological ... | 合法醫療器材資訊網

2021年6月3日——PhysiciansmuststopimplantingtheHeartWaresystem,saysFDA...TheHeartWaresystemisnowoffthetableforleftventricularassistdevice ...

The HeartWare system is now off the table for left ventricular assist device (LVAD) candidates with advanced heart failure, the FDA announced[1].

Medtronic is halting the global distribution and sale of the HeartWare system following observational evidence associating the LVAD with increased neurological adverse events and mortality compared with similar mechanical circulatory support (MCS) devices.

Some HeartWare LVADs had already been recalled in December 2020 because of complaints that the pump may delay or fail to start. To date, there have been over 100 of these complaints, including reports of 14 patient deaths and 13 cases where an explant was necessary, the FDA noted.

"We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace," said Bram Zuckerman, MD, director of the Office of Cardiovascular Device...