Tag: HVAD

Medtronic to Stop Distribution and Sale of HVAD™ System

– Company Developing Support Program for Current HVAD Patients – Medtronic Coordinating with Global Regulators to Assure Patient Access to Left Ventricular Assist Devices DUBLIN, June 3, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, is stopping the distribution and sale of the Medtronic HVAD™ System. This morning, the […]

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

SILVER SPRING, Md., June 3, 2021 /PRNewswire/ — 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 […]

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]