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U.S. readies global Covid vaccine donations


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With Katherine Ellen Foley, Rachel Roubein and Emily Martin.
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The U.S. will send about 75 percent of its next batch of Covid shot donations to COVAX, with the rest going directly to allies and priority regions. ....

New York , United States , White House , District Of Columbia , South Africa , Tim Scott , Phillip Febbo , Conor Sheehey , Liz Fowler , David Lim , Erin Banco , Bram Zuckerman , Adam Cancryn , Michael Felberbaum , Timothy Stenzel , James Boiani , Helen Collis , Amy Abernethy , Rachel Roubein , Emily Martin , Amanda Eisenberg , Katherine Ellen Foley , Toby Lowe , Lauren Gardner , Purdue Pharma , Udall Foundation ,

FDA alerts health care providers to no longer implant heart failure patients with Medtronic's HVAD System


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 ....

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