First human implant of new style Australian artificial heart

On 22 March 2006, a 48 year old male patient suffering NYHA Class IV Heart Failure became the first recipient of HeartWare's HVAD mechanical circulatory assist device.

The implant was conducted at the Vienna General Hospital and the surgical team was led by Dr Georg Wieselthaler, Clinical Director of Mechanical Circulatory Support at the University of Vienna.

The successful implant marks the start of HeartWare's CE mark clinical study. The trial protocol calls for the implantation of the device in twenty patients suffering advanced heart failure. The implants are to be conducted at the Vienna General Hospital (Austria), the Royal Perth Hospital (Australia), the Hannover Medical Centre (Germany) and Harefield Hospital (UK). HeartWare expects to complete patient enrolment in the trial by the end of 2006.

Commenting on the first implant, Dr Wieselthaler said:

"Our first clinical experience of the HVAD was extremely positive. The procedure was completed quickly and without incident, and our patient's early post-operative recovery has been excellent.

The device's small size and configuration facilitated a relatively fast implant procedure. The surgery took only 85 minutes, significantly less than the time typically required to implant other devices. The patient was moved from the operating theatre into the post operative recovery area, conscious and off ventilation within seven hours. He continues to recover quickly and has met with his family. We are very pleased with these results."

HeartWare CEO, Mr Stuart McConchie, commented from Vienna:

"The performance of the HVAD continues to support our high expectations for its clinical potential. The early success of this first implant marks the culmination of many years of effort in conceiving, designing, developing and testing what we believe to be the world's leading mechanical circulatory assist device.

The HVAD is the smallest 3rd generation circulatory assist device available. It is the only full-output pump implantable in the pericardial space and the only centrifugal pump implantable above the diaphragm. The pump's impeller design, together with its integrated inflow cannula, help to ensure optimal blood flow characteristics which should, over time, allow reduction of the anticoagulant levels typically required for LVAD recipients.

The HVAD's unique design should allow long term device durability - providing the genuine prospect of "lifelong" therapy. We are extremely encouraged by the early results of our first implant and look forward to confirming and replicating these results through the course of the clinical trial. I would particularly like to recognise the efforts of the dedicated teams at HeartWare and at Vienna General Hospital who together have made this initial implant possible."

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