Data released from the bridge-to-transplantation (BTT) arm of the HeartMate II Pivotal trial demonstrate that the device provides effective mechanical circulatory support as a bridge to transplantation for heart failure patients, and that these patients experience a lower number of adverse events and an improved quality of life while being supported by the device.
The data were presented at a late breaking clinical trial session of the ACC Sessions by Dr. Leslie Miller of Washington Hospital Medical Center/Georgetown University on behalf of the HeartMate II investigators.
The trial involved 133 patients enrolled at 26 centers from March 2005 through May 2006, and the data reported reflect patient follow-up through the end of December 2006. Thoratec completed its PreMarket Approval (PMA) filing seeking approval for the BTT indication at the end of 2006.
The HeartMate II, which has a CE mark allowing for its commercial sale in Europe, is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, it is significantly smaller than devices currently having PMA approval, enabling an easier implantation in a broader population of patients. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. The device pumps blood through the circulatory system on a continuous basis with only one moving part.