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 for its in-development fully implantable left ventricular assist system (FILVAS)....

FDA approves Abbott heart pump for less invasive surgical approach

Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that the...

Medtronic announces global registry of HVAD thoracotomy implants

  Medtronic has announced plans for a global registry of its HeartWare HVAD System, following the release of two-year outcomes from the LATERAL clinical trial....

HeartWare HVAD system receives US FDA approval

Medtronic has received United States Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD System, a left ventricular assist...

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 in heart failure patients in need of short-term...
Woman patient

Heart failure patient and clinician risk perceptions differ drastically

Physicians identified a majority of patients with advanced heart failure as at high risk for transplant, left ventricular assist device (LVAD) or death while...

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 less-invasive implant procedure in patients with advanced heart failure....

FDA approve clinical trial of a miniature heart assist device for...

The FDA has granted conditional approval to conduct an investigational device exemption (IDE) study of Jarvik Heart’s new miniature left ventricular assist device (LVAD)...

Purchase of HeartWare by Medtronic completed

Medtronic has completed its acquisition of HeartWare International—a developer of less-invasive, miniaturised, mechanical circulatory support technologies for treating patients with advanced heart failure. HeartWare...