FDA panel recommends approval for Thoratec ventricular assist system

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Dec. 6 – The FDA Circulatory System Devices Advisory Panel has recommended unanimously that the agency approve, with conditions, the Thoratec’s pre-market approval (PMA), allowing the use of its HeartMate II left ventricular assist system (LVAS) as a bridge-to-transplantation (BTT).

The HeartMate II is a continuous flow device designed to provide cardiac support for advanced-stage heart failure, according to the Pleasanton, Calif.-based Thoratec.

The leading clinical presenters were Leslie Miller, MD, chair of cardiovascular medicine and director of cardiology programs at Washington Hospital Center and Georgetown University Hospital, and Francis Pagani, MD, director of the Heart Transplant Program at the University of Michigan Hospital.

Thoratec said the conditions outlined in the panel's recommendations related to clarifications on labeling for the device regarding small patients, who are unable to be treated with anti-coagulation therapy, and elements of the post-approval study.