Abbott (NYSE: ABT) today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory support (MCS) devices for the effective treatment of advanced heart failure following Medtronic's decision to stop the global distribution and sale of the Medtronic HeartWare™ .
/PRNewswire/ Abbott (NYSE: ABT) today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory.
/PRNewswire/ The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic s.
FDA alerts health care providers to no longer implant heart failure patients with Medtronic s HVAD System
The U.S. Food and Drug Administration is alerting 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 requesting physicians to stop new implants of the device. This action comes after the company received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was neces