SO MUCH DATA IN SUCH A SMALL DEVICE
Medtronic is pleased to announce our Destination Therapy (DT) indication for the HeartWare HVAD System, and share the data that supports this important advancement in mechanical circulatory support therapy. With this indication, the HeartWare HVAD Pump is the only intrapericardial VAD with two years of data that is approved for DT.
"In the ENDURANCE trial, we were concerned about the higher rate of stroke in the HVAD group compared to the control. In the ENDURANCE Supplemental trial, that gap closed and the stroke rates are now comparable: there was no clinically significant difference between the HVAD and HeartMate II™. We believe the narrowing of those rates was most likely due to blood pressure management."
Carmelo Milano, M.D., co-principal investigator. Surgical Director. Cardiac Transplantation and Left Ventricular Assist Device (LVAD) Programs. Division of Cardiothoracic Surgery. Duke University Medical Center. Durham, N.C.