Tag: HVAD

Targeted blood pressure management helps to reduce strokes in patients with...

An analysis on the impact of stroke severity in patients receiving the HeartWare HVAD system (Medtronic) as destination therapy shows that targeted blood pressure...

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...

US FDA classifies HeartWare HVAD power issues as a Class I...

The US FDA has classified Medtronic’s recent voluntary urgent field action related to the HeartWare HVAD system’s unexpected power source switching as a Class...

Medtronic HeartWare HVAD approved for destination therapy

The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who...

US FDA designates Medtronic HVAD system controller field action as class...

The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntary field action related to its HVAD system controllers and direct current...

LATERAL study offers positive overall results for Medtronic HVAD

Preliminary results from the Medtronic -sponsored HVAD LATERAL study have demonstrated overall positive results. The data were presented as a late breaking clinical trial...

Medtronic ENDURANCE Supplemental trial of HVAD fails to meet primary endpoint

Medtronic’s ENDURANCE Supplemental trial of the company’s HVAD ventricular assist device has failed to meet its primary endpoint of all neurological events at 12...

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 deems two HeartWare HVAD recalls as “Class I”

Medtronic has reported that two previously communicated global voluntary recalls related to the HeartWare HVAD System have been categorised as Class 1 by the...

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...