Recent disappointing results for ventricular assist device companies are raising questions over adoption of the technology—which is meant to assist patients’ weakened hearts with pumping blood. HeartMate II, as shown on ...
Approximately one year after the company landed FDA approval for its Ventricular Assist System, the company is boasting significant surge in revenue. In early morning trading on November 7, the company's shares increased by 15%. In total, ...
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
The US Food and Drug Administration (FDA) has granted approval to HeartWare International's miniaturized ventricular assist system. The HeartWare system, which includes a HVAD circulatory assist device with a sintered inflow cannula, ...
Tags: ventricular assist system, cardiac transplantation, FDA