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Promising Results From C-Pulse Heart Assist Device Trials
26 / 10 / 2005
Sydney, Australia: Dr Paget Milsom, the principal investigator of the CPulse heart assist device, today presented new data supporting that C-Pulse as a promising option for patients with heart failure at the Annual Scientific Meeting of the Australasian Society of Cardiothoracic Surgeons in Queensland.
Dr Milsom presented data from the implant of the C-Pulse heart assist device in the first two patients which showed that the surgery and C-Pulse device are safe, and the device provided effective counter-pulsation.
He told the audience of Cardiothoracic surgeons that: "The C-Pulse is a promising option for patients with heart failure as it increases coronary flow, decreases heart loading and provides non-obligatory augmentation, i.e. it can be turned on and off as required." With respect to possible complications Dr Milson reported that the results to date showed no concerns with respect to bleeding, the formation of blood clots or device failure.
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.
"This is an independent peer reviewed validation of the C-Pulse technology," said Don Rohrbough, CEO of Sunshine Heart.
"The first two patients implanted with the C-Pulse did not reveal the true potential of the device, however the very positive outcomes are shown in today's presentation".
The first patient implanted with the C-Pulse died of multi-organ failure on day 80 of the trial, for reasons not related to the implant. The second patient developed an infection at day 33 and the implant needed to be removed, followed by antibiotic treatment.
In reference to the death of the first patient Dr Milsom noted that the literature reported 38% of patients receiving conventional heart assist devices died of multi-organ failure. In reference to the infection he stated that the literature reported 32.5% of patients receiving conventional heart assist devices suffered infection post-implant.
Sunshine Heart is conducting a multi-site 10 person trial. The trial is continuing in New Zealand and will commence in Australia shortly.
More information about the C-Pulse heart assist device, and a copy of the presentation made by Dr Milsom, may be obtained at www.sunshineheart.com.
Dr Milsom presented data from the implant of the C-Pulse heart assist device in the first two patients which showed that the surgery and C-Pulse device are safe, and the device provided effective counter-pulsation.
He told the audience of Cardiothoracic surgeons that: "The C-Pulse is a promising option for patients with heart failure as it increases coronary flow, decreases heart loading and provides non-obligatory augmentation, i.e. it can be turned on and off as required." With respect to possible complications Dr Milson reported that the results to date showed no concerns with respect to bleeding, the formation of blood clots or device failure.
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.
"This is an independent peer reviewed validation of the C-Pulse technology," said Don Rohrbough, CEO of Sunshine Heart.
"The first two patients implanted with the C-Pulse did not reveal the true potential of the device, however the very positive outcomes are shown in today's presentation".
The first patient implanted with the C-Pulse died of multi-organ failure on day 80 of the trial, for reasons not related to the implant. The second patient developed an infection at day 33 and the implant needed to be removed, followed by antibiotic treatment.
In reference to the death of the first patient Dr Milsom noted that the literature reported 38% of patients receiving conventional heart assist devices died of multi-organ failure. In reference to the infection he stated that the literature reported 32.5% of patients receiving conventional heart assist devices suffered infection post-implant.
Sunshine Heart is conducting a multi-site 10 person trial. The trial is continuing in New Zealand and will commence in Australia shortly.
More information about the C-Pulse heart assist device, and a copy of the presentation made by Dr Milsom, may be obtained at www.sunshineheart.com.