Tag: LVAD
FDA Breakthrough Device Designation for fully implantable left ventricular assist system
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott ...
FDA approves Abbott heart pump for less invasive surgical approach
Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgica...
Medtronic announces global registry of HVAD thoracotomy implants
Medtronic has announced plans for a global registry of its HeartWare HVAD System, foll...
HeartWare HVAD system receives US FDA approval
Medtronic has received United States Food and Drug Administration (FDA) approval for a less-invasi...
Abbott’s Full MagLev HeartMate 3 LVAD receives FDA approval
The FDA has approved the Full MagLev HeartMate 3 (Abbott) left ventricular assist device for use...
Heart failure patient and clinician risk perceptions differ drastically
Physicians identified a majority of patients with advanced heart failure as at high risk for transpl...
Medtronic first to receive CE mark for less-invasive HVAD implant procedure
Medtronic’s HVAD system left ventricular assist device (LVAD) has received the CE mark for a les...
FDA approve clinical trial of a miniature heart assist device for infants and children
The FDA has granted conditional approval to conduct an investigational device exemption (IDE) st...
Purchase of HeartWare by Medtronic completed
Medtronic has completed its acquisition of HeartWare International—a developer of less-invasive,...
