First U.S. Implant of the HeartWare LVAS Announced


August 22, 2008

August 22, 2008 - HeartWare Ltd. this week said the first patient in the U.S. received the HeartWare Left Ventricular Assist System (LVAS) at Washington Hospital Center (WHC) in Washington, D.C.

This marks the start of HeartWare’s U.S. Bridge-to-Transplant clinical trial, under which 150 patients awaiting heart transplantation will be enrolled at up to 28 participating centers. The HeartWare LVAS features a miniature blood pump that can be placed adjacent to the patient’s heart, and is designed to avoid potentially more complicated abdominal implantation. The system is designed to provide circulatory support for patients with advanced heart failure. The HeartWare LVAS is limited to investigational use in the U.S.

The principal investigator at WHC is Dr. Leslie Miller. The surgery was performed by Steven Boyce, M.D., surgical director, heart failure program at WHC.

“Like many of our colleagues, we have been closely watching HeartWare’s progress and have been impressed by the results from the international clinical trial,” said Drs. Miller and Boyce in a joint statement. “We at Washington Hospital Center are pleased to have been the first to implant this exciting new device. The surgery was quick and without incident and the patient is recovering well. The novel configuration of the HeartWare device together with its small size allow the pump to be implanted in the pericardial space, potentially reducing the risks associated with more extensive surgery. The pump has one moving part, an impeller that utilizes a passive suspension system designed to minimize mechanical wear and friction while pumping. We look forward to Washington Hospital Center’s continued use of the device through the course of this trial.”

The company expects a number of additional centers to complete their internal review processes and to begin enrolling patients over the next several months.

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