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Sunshine Heart Prepares for First Clinical Trial in Australia
08 / 11 / 2005
Key points:
- Sunshine Heart, Inc. receives Ethics Committee Approval from Southern Health
Monash Medical Centre, Clayton Victoria, to extend its clinical trial for the C-Pulse
heart assist implant.
- Southern Health is one of two Victorian hospitals expected to trial the C-PulseT in
Australia.
- Should the results from the Australian trial be successful, a larger global trial will be
conducted.
Sydney, Australia. 8 November 2005: Sunshine Heart Inc., (ASX: SHC) is preparing for the first clinical trial of the C-PulseT heart assist device in Australia, following today's announcement that ethics approval for the clinical trial has been awarded to the Investigators at Southern Health Monash Medical Centre in Melbourne.
The Human Research Ethics Committee at Southern Health has given permission for the recruitment of a first heart failure patient to be implanted with the C-PulseT heart assist device, followed by review at three months. This trial is part of a larger trial in Australia and New Zealand involving up to ten patients. The first two patients to be implanted with the CPulseT earlier this year were treated at Auckland City Hospital. Discussions are progressing with other trial centres including another Melbourne centre.
Professor Julian Smith, Principal Investigator and Head of Cardiothoracic Surgery at Southern Health commented: "The treatment options for people in this category of heart failure are limited, so there is a real need for a device such as the C-PulseT. We are pleased to be able to pioneer the C-PulseT technology offered by Sunshine Heart within Australia."
Dr William Peters, Medical Director of Sunshine Heart, added: "The C-Pulse heart assist device is designed to improve the heart function of patients in heart failure by increasing blood supply to the heart muscle and by reducing the pumping work the heart has to do This is achieved without the device contacting blood, making it safe to turn the device on and off."
Donald Rohrbaugh, CEO of Sunshine Heart Inc. added: "It is great news that Australian centres will participate in the pilot trial of this unique device that is being developed locally."
The long term trial will enrol patients who, despite maximal medical therapy, are repeatedly hospitalised with heart failure. The C-PulseT heart assist device is intended to provide therapy to those patients throughout their lives.
More information about the C-PulseT heart assist device may be obtained at
www.sunshineheart.com.
For further information, please contact:
Media
Daniella Goldberg PhD
+612 9237 2800 / 0416 211 067
[email protected]
Investor Relations
Rebecca Wilson
+612 9237 2800 / 0417 382 391
[email protected]
Sunshine Heart
Crispin Marsh
Director of Corporate Affairs
+61 2 9818 7913
[email protected]
Don Rohrbaugh
CEO
+1 714 665 1951
[email protected]
- Sunshine Heart, Inc. receives Ethics Committee Approval from Southern Health
Monash Medical Centre, Clayton Victoria, to extend its clinical trial for the C-Pulse
heart assist implant.
- Southern Health is one of two Victorian hospitals expected to trial the C-PulseT in
Australia.
- Should the results from the Australian trial be successful, a larger global trial will be
conducted.
Sydney, Australia. 8 November 2005: Sunshine Heart Inc., (ASX: SHC) is preparing for the first clinical trial of the C-PulseT heart assist device in Australia, following today's announcement that ethics approval for the clinical trial has been awarded to the Investigators at Southern Health Monash Medical Centre in Melbourne.
The Human Research Ethics Committee at Southern Health has given permission for the recruitment of a first heart failure patient to be implanted with the C-PulseT heart assist device, followed by review at three months. This trial is part of a larger trial in Australia and New Zealand involving up to ten patients. The first two patients to be implanted with the CPulseT earlier this year were treated at Auckland City Hospital. Discussions are progressing with other trial centres including another Melbourne centre.
Professor Julian Smith, Principal Investigator and Head of Cardiothoracic Surgery at Southern Health commented: "The treatment options for people in this category of heart failure are limited, so there is a real need for a device such as the C-PulseT. We are pleased to be able to pioneer the C-PulseT technology offered by Sunshine Heart within Australia."
Dr William Peters, Medical Director of Sunshine Heart, added: "The C-Pulse heart assist device is designed to improve the heart function of patients in heart failure by increasing blood supply to the heart muscle and by reducing the pumping work the heart has to do This is achieved without the device contacting blood, making it safe to turn the device on and off."
Donald Rohrbaugh, CEO of Sunshine Heart Inc. added: "It is great news that Australian centres will participate in the pilot trial of this unique device that is being developed locally."
The long term trial will enrol patients who, despite maximal medical therapy, are repeatedly hospitalised with heart failure. The C-PulseT heart assist device is intended to provide therapy to those patients throughout their lives.
More information about the C-PulseT heart assist device may be obtained at
www.sunshineheart.com.
For further information, please contact:
Media
Daniella Goldberg PhD
+612 9237 2800 / 0416 211 067
[email protected]
Investor Relations
Rebecca Wilson
+612 9237 2800 / 0417 382 391
[email protected]
Sunshine Heart
Crispin Marsh
Director of Corporate Affairs
+61 2 9818 7913
[email protected]
Don Rohrbaugh
CEO
+1 714 665 1951
[email protected]