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World First C-Pulse Heart Failure Device

World First C-Pulse Heart Failure Device

For immediate release Monday 9 May 2005

WORLD FIRST C-PULSE HEART FAILURE DEVICE

Patient in long term heart failure receives new hope through C-Pulse heart failure device

A 56-year old New Zealand man has become the first person to be implanted with the C-Pulse heart device developed by Australian company Sunshine Heart, Inc.

The world first operation took place at Auckland City Hospital on 4th May with doctors today releasing details of the successful implantation.

The operation went smoothly, the device is working well, and the patient is recovering quickly with good improvement in heart performance. The implant took 2.5 hours, and was done without using a heart-lung bypass machine or stopping the heart.

“This patient had suffered heart failure for 9 years and had a very limited quality of life. He had been hospitalized on 6 occasions in the last 18 months,” said Dr Paget Milsom, Head of Cardiothoracic Surgery at Auckland City Hospital.

“C-Pulse therapy was considered the best option to improve the life of this patient. We are delighted to be able to offer this patient a device that is quite unlike anything previously used for the treatment of heart failure. Following the surgery, the device is working well and the patient is showing augmentation of his native heart function.”

The Sunshine Heart C-Pulse is an implantable, non-blood contacting mechanical heart assist device powered by an external driver unit. The C-Pulse works to reduce the load on the heart and to assist the heart to pump blood.

“The successful world-first implantation of the non-blood contacting heart-assist C-Pulse represents a medical milestone and heralds a paradigm shift in the approach to mechanical circulatory support. It is also a key milestone for the company,” said CEO of Sunshine Heart, Inc, Mr. Donald Rohrbaugh.

“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-Pulse. The supply of donor hearts for transplantation is well below the number needed and only about 30% of patients are suitable for heart failure treatment with a pacemaker that can help to correct the pumping rhythm of the failing heart,” added Dr William Peters MD, Clinical Research Fellow in Cardiothoracic Surgery at Auckland City Hospital and Medical Director of Sunshine Heart.

“Follow-up measurements of quality of life and heart function will be completed in this patient at 3 and 6 months. Up to 10 patients will be enrolled in the study. Additional study centres are expected to be opened at leading hospitals in Australia in the future,” Dr Peters said.

Heart failure is a progressively worsening condition characterized by shortness of breath with mild exercise, fatigue, dizziness and fluid retention. Its cause is the inability of the heart to pump sufficient blood around the body to meet its oxygen requirement.

It has been estimated that 325,000 people in Australia have symptomatic heart failure, and that there are 22,000 admissions to hospital for heart failure each year. Heart failure is believed to contribute to over 1.4 million days of hospitalization annually at a cost of more than $1B. In excess of 5 million people in the USA have heart failure.

Avoiding blood contact makes C-Pulse implantation less complex and less costly when compared to most other blood-contacting heart pumps, and reduces the risks of bleeding complications. Avoiding blood contact also allows the C-Pulse device to be safely turned on and off.

The C-Pulse has three main components:

* A cuff which consists of a wrap and a balloon. The cuff is secured around the ascending aorta (the main blood vessel carrying blood from the heart to the body). The balloon is inflated and deflated in time with the heart rhythm to improve blood supply to the body and to the heart muscle itself, as well as reducing the work load of the heart.

* A sensing lead which conveys the heart's electrical signals to the driver unit

* A wearable driver unit which is linked by an air tube to the cuff and which causes the balloon in the cuff to inflate and deflate in rhythm with the heart

The C-Pulse is unique as compared with other heart assist devices currently on the market such as the Left Ventricular Assist Devices (LVADs). It is the only device that does not come into direct contact with the blood and it requires a less invasive surgical procedure. It is also non-obligatory, meaning that if its function is interrupted, the situation is not life-threatening and the patient is much less likely to have an adverse reaction than if an LVAD failed.

(end)

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