Successful First Implant Of C-Pulse Heart Device

Successful First Implant Of C-Pulse Heart Failure Device

Sunshine Heart successful first implant of C-Pulse heart failure device

In summary:

* 56 year old man in Class III heart failure was successfully implanted with the first non-blood contacting C-Pulse device for the treatment of heart failure.

* C-Pulse is designed to meet a major demand for better treatment options for people in moderate (Class III) heart failure.

* C-Pulse is distinctly different to left ventricular heart assist devices (LVADs) - it's non blood contacting, simpler, safer, smaller, less expensive, easier to implant and can be turned on and off.

* There are an estimated 325,000 Australians with symptomatic heart failure and there are more than 5 million people in the USA with heart failure. Heart failure contributes over 1.4 million days of hospitalisation each year in Australia at an estimated cost of more than $1 billion.

Sydney, 9 May, 2005: Sunshine Heart (ASX:SHC) announced today the success of the first long-term implantation of its C-Pulse device for the treatment of heart failure. The 56-year-old male patient with Class III heart failure received the device on 4 May 2005 at Auckland City Hospital and is recovering following the 2.5 hour operation.

The C-Pulse is designed to treat people with moderate (NYHA Class III) heart failure who stand to gain, post-implantation, a substantial improvement to a poor quality of life. Patients in Class III heart failure struggle to walk short distances and get short of breath with minimal exertion. Such patients are subject to frequent hospitalisation.

Trial details

This is the first long-term implantation trial for Sunshine Heart's C-Pulse device. Key elements of the trial are:

* Operation was completed at the Green Lane Cardiothoracic Unit at Auckland City Hospital, led by Head of Cardiothoracic Surgery, Dr Paget Milsom and transplant cardiologist Dr Peter Ruygrok.

* Primary endpoints of the trial are Improvement in Quality of Life, measured by NYHA Class, Minnesota Living with Heart Failure Score, and Six Minute Walk Test at six months post-implant. Secondary endpoints are measures of heart size and function as determined by echocardiography, and measures of safety, including all adverse events.

* The trial is non-blinded and seeks to enroll up to 10 patients. Suitable patients are aged 18-80 years, in NYHA Class III heart failure and with no significant ascending aortic disease or aortic valve leakage nor intact aorto-coronary grafts.

* Additional centres for the trial are expected to be established at leading hospitals in Australia.

Treatment options

The treatment options for people in this category of moderate heart failure are limited. Typically they will already be on maximal drug therapy but are not yet sick enough to receive a conventional heart assist device, such as an LVAD. Between 20% and 30% of these patients may be assisted by a cardiac resynchronisation pacemaker, which is able to assist patients whose heart failure is associated only with a particular electrical dysfunction of the heart.

Competitive advantage

Other mechanical heart assist devices, known as left ventricular assist devices, or LVADs, are typically only used in patients with severe (Class IV) heart failure.

The C-Pulse is distinctly different:

* It never comes into contact with the blood. It consists of a balloon cuff wrapped around the outside of the major artery from the heart (the aorta) which pumps in time with the heartbeat with an action called 'aortic counterpulsation'.

* The C-Pulse is simpler, safer, smaller and easier to implant. It has the added advantage that it can be turned on and off, unlike LVADs which must run continuously to keep the patient alive.

* The C-Pulse can be surgically implanted at any hospital that performs heart surgery and without the need for the sophisticated facilities of a transplant centre. The operation does not require the patient to be placed on a heart-lung machine, further reducing the risk of the procedure.

Market size

Heart failure is a progressively worsening condition characterised by shortness of breath, fatigue, dizziness and fluid retention. In Australia it has been estimated that there are 325,000 people (56% male) with symptomatic heart failure. This costs the Australian community more than $1 billion per annum covering 1.4 million days of hospitalisation (Clark, R.A. et al., "Uncovering a hidden epidemic: A study of the current burden of heart failure in Australia" Heart Lung and Circulation;13:266-273). The American Heart Association has estimated that there are 5.3 million people in the US with heart failure. They estimate that approximately US$2.8 billion is spent on re-hospitalisation of Class III patients in the US alone, and in 2004, the estimated direct and indirect cost of heart failure (all Classes) in the US was US$25.8 billion (American Heart Association data).

More information about the C-Pulse heart assist device may be obtained at www.sunshineheart.com .

The shares of Sunshine Heart have not been registered under the Securities Act of 1933 (the "US Securities Act") and may not be offered, sold or delivered in the United States, or to, or for the account or benefit of, any US Person, as such term is defined in Regulation S of the US Securities Act. In addition, hedging transactions with regard to the shares may not be conducted unless in accordance with the US Securities Act.

© Scoop Media