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Successful second Sunshine C-Pulse implant
01 / 08 / 2005
Sydney, Australia
In a continuation of a 10-patient, long-term pilot clinical trial, a second person with heart failure has been successfully implanted with the C-Pulse counterpulsation pump from Sunshine Heart, Inc (ASX: SHC).
As with the first C-Pulse implantation, the surgery took place at Auckland City Hospital. The operation proceeded smoothly and was completed in just over 2 hours. There was no need to place the patient on a heart lung machine, nor did the patient require a blood transfusion or other blood products.
After 24 hours in intensive care, the patient was discharged to a general ward where he is continuing his recovery from the procedure. The C-Pulse implantable counterpulsation pump is operating well with no complications.
Surgical teams from two leading Australian heart centres attended the operation. This allowed these clinicians to observe the procedure first hand as part of their training in preparation for the Australian centres entering the clinical trial. The clinicians were impressed with the simplicity of the procedure, the speed with which it could be completed and the immediate effect of the C-Pulse device.
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.
"Patients enrolled for the C-Pulse trial have severely compromised health, typically having had heart failure for several years," said Dr William Peters, Clinical Research Fellow in Cardiothoracic Surgery at Auckland City Hospital and Medical Director of Sunshine Heart.
"People who have heart failure despite optimal medical therapy are candidates for either heart transplantation or mechanical heart assistance. However, the risk of death in the first 30 days following surgery is very high in these patients. The C-Pulse can be implanted quickly and without the need for the heart-lung machine, and can be used immediately to support heart function.
The C-Pulse device thus offers a potentially lower surgical implant risk and may provide a good long-term benefit from augmenting heart function. It is expected that in the future the C-Pulse will be placed in less sick patients, however in this initial pilot clinical trial the C-Pulse is providing support for very sick patients who have no other treatment options."
FURTHER INFORMATION
Trial details
This is the second long-term implantation trial for Sunshine Heart''s C-Pulse device.
Key elements of the trial are:
Operation was completed at the 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.
About heart failure
Heart failure is a progressively worsening condition characterized by shortness of breath with mild exercise, fatigue, dizziness and fluid retention. It is caused when the heart is unable to pump sufficient blood around the body to meet the requirement for oxygen. About 325,000 people in Australia and more than 5 million in the USA are estimated to have symptomatic heart failure. In Australia, there are about 22,000 admissions to hospital for heart failure each year.
About the C-Pulse
A key advantage of the C-Pulse o
In a continuation of a 10-patient, long-term pilot clinical trial, a second person with heart failure has been successfully implanted with the C-Pulse counterpulsation pump from Sunshine Heart, Inc (ASX: SHC).
As with the first C-Pulse implantation, the surgery took place at Auckland City Hospital. The operation proceeded smoothly and was completed in just over 2 hours. There was no need to place the patient on a heart lung machine, nor did the patient require a blood transfusion or other blood products.
After 24 hours in intensive care, the patient was discharged to a general ward where he is continuing his recovery from the procedure. The C-Pulse implantable counterpulsation pump is operating well with no complications.
Surgical teams from two leading Australian heart centres attended the operation. This allowed these clinicians to observe the procedure first hand as part of their training in preparation for the Australian centres entering the clinical trial. The clinicians were impressed with the simplicity of the procedure, the speed with which it could be completed and the immediate effect of the C-Pulse device.
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.
"Patients enrolled for the C-Pulse trial have severely compromised health, typically having had heart failure for several years," said Dr William Peters, Clinical Research Fellow in Cardiothoracic Surgery at Auckland City Hospital and Medical Director of Sunshine Heart.
"People who have heart failure despite optimal medical therapy are candidates for either heart transplantation or mechanical heart assistance. However, the risk of death in the first 30 days following surgery is very high in these patients. The C-Pulse can be implanted quickly and without the need for the heart-lung machine, and can be used immediately to support heart function.
The C-Pulse device thus offers a potentially lower surgical implant risk and may provide a good long-term benefit from augmenting heart function. It is expected that in the future the C-Pulse will be placed in less sick patients, however in this initial pilot clinical trial the C-Pulse is providing support for very sick patients who have no other treatment options."
FURTHER INFORMATION
Trial details
This is the second long-term implantation trial for Sunshine Heart''s C-Pulse device.
Key elements of the trial are:
Operation was completed at the 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.
About heart failure
Heart failure is a progressively worsening condition characterized by shortness of breath with mild exercise, fatigue, dizziness and fluid retention. It is caused when the heart is unable to pump sufficient blood around the body to meet the requirement for oxygen. About 325,000 people in Australia and more than 5 million in the USA are estimated to have symptomatic heart failure. In Australia, there are about 22,000 admissions to hospital for heart failure each year.
About the C-Pulse
A key advantage of the C-Pulse o