Thoratec has gained an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for the initiation of a feasibility clinical study of its continuous-flow left ventricular assist device (LVAD), for the treatment of Class III heart failure.
HeartMate II device, which features a continuously spinning rotor, is attached with an external, wearable system including a small controller and two batteries by a percutaneous driveline.
The device pumps up to 10 liters of blood per minute and is placed just below the diaphragm for connecting it to the left ventricle, which carries oxygenated blood to the entire body.
The controlled, prospective Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) trial, which will enroll up to 100 patients, will compare the use of the HeartMate II with optimal medical management (OMM).
Composite measure of survival, freedom from disabling stroke, and improvement in functional outcomes, as measured by the six-minute walk test, are the primary endpoints of the study.
REVIVE-IT study is being sponsored by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and Thoratec, through a $5m contract from the NHLBI and a funding commitment of up to $11m from Thoratec.
Center for Circulatory Support at University of Michigan Cardiovascular Center surgical director Francis Pagani said the HeartMate II device has been studied for long-term support of advanced heart failure patients and has a well-defined efficacy and safety profile.
"We look forward to exploring its utilization and potential benefits, including extended survival and improved functional status, in earlier-stage patients," Pagani added.