US FDA Approves Medtronic's HVAD For Destination Therapy
The expanded labeling gives Medtronic's HVAD, acquired when it bought HeartWare last summer, the same indication as Abbott's HeartMate II ventricular assist device.
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Following a €2.5m award from the European Commission’s EIC Accelerator Program, Paris based CorWave has become the first EU company to obtain EIC fund investment. The company is developing a new pulsatile LVAD.
A post-hoc analysis of the combined data from the ENDURANCE and ENDURANCE Supplemental trials shows a relationship between severely disabling stroke and one-year mortality in patients treated with Medtronic’s HeartWare HVAD as well as other left-ventricular assist devices (LVAD), including Abbott’s HeartMate II, and that blood-pressure control significantly reduces the risk of stroke events from six-months to two-years post-implant.
New clinical data with the potential to change clinical practice will be presented at the 2018 American College of Cardiology Scientific Session and Expo in Orlando, Fla., Mar. 10-12. Among the planned late-breaking trials and featured research presentations is a study of Zoll's LifeVest wearable external cardioverter-defibrillator following a heart attack; new results from a trial of Abbott's Amplatzer PFO-closure device, and long-term data on Abbott's HeartMate 3 ventricular assist device.