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
Contact: Howard Leibman