November 21st, 2012
HeartWare LVAD Approved By FDA For Transplant Patients
Larry Husten, PHD
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal ADVANCE trial, in which 140 […]
April 26th, 2012
FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System
Larry Husten, PHD
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device […]
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