HeartWare to begin human implants of HVAD device in heart failure patients

By E. Janene Geiss

Philadelphia, March 8 - HeartWare Ltd. announced Wednesday that the Australian Therapeutic Goods Administration has approved the start of human implants of the HVAD Left Ventricular Assist Device.

The administration's approval follows the recent receipt of ethics approval from the Royal Perth Hospital, according to a company news release.

The company said it now has approval from the regulatory authorities in both Austria and Australia to begin human implants of the device. HeartWare said it has completed its surgeon-training program, which was conducted at the Texas Heart Institute.

"HeartWare's primary stated objective since our IPO in January 2005 has been to commence human implants of the HVAD during the first quarter of 2006. Having now received approvals in two key jurisdictions, we remain confident of achieving this important milestone," Stuart McConchie, chief executive officer, said in the release.

The forthcoming human implants of the device are part of the company's CE Mark trial. The trial protocol calls for the implantation of the HVAD in 20 patients with advanced heart failure.

The company said its objective is to complete all 20 implants by the end of the year. Subject to this time frame, HeartWare said it expects to receive CE Mark in the third quarter of 2007 at which time commercial sales in Europe and Australia can begin, officials said.

HeartWare is a Sydney, Australia, medical device company developing a family of proprietary circulatory assist devices to treat patients with congestive heart failure.

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