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news.Thoratec Corporation has announced that the FDA Circulatory System Devices Advisory Panel has unanimously recommended premarket approval for the use of its HeartMate II LVAS as a bridge-to-transplantation.
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The conditions outlined in the panel’s recommendations related to clarifications on labeling for the device regarding small patients and those unable to be treated with anti-coagulation therapy, and elements of the post-approval study.
The HeartMate II left ventricular assist system (LVAS) is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure.
Commenting on the panel’s recommendation, Gary Burbach, president and CEO of Thoratec, said: “This represents a major step in our program to make this state-of-the-art circulatory support technology commercially available in the US for patients suffering from advanced-stage heart failure. We believe the data reflect the positive experience of patients in the trial, and that the HeartMate II represents a significant breakthrough in the treatment of heart failure and look forward to continuing what has been to date a positive dialog with the FDA around this submission and achieving approval.”