Wednesday 24 November 2004
Sunshine Heart begins short-term patient trial
Sydney, Australia. Wednesday 24 November 2004: Sunshine Heart Inc., (ASX: SHC) today announced that a C-Pulse heart assist device was placed intra-operatively (for a short time) in a patient in New Zealand as the first of a 6 patient trial. This placement is important not only as part of the ongoing intra-operative trial but also as a precursor to the long term human clinical trial expected to commence in New Zealand in December.
Clinical investigators at Auckland City Hospital undertook the first intra-operative placement of the Sunshine Heart C-Pulse heart assist device yesterday. The patient was a 74 year old female with NYHA Class III heart failure and an ejection fraction of 25% who was undergoing coronary artery bypass grafting. This intra-operative study’s indications had recently been expanded from use in patients about to get a heart transplant, to any patient with poor heart function having heart surgery – thus allowing a much faster expected recruitment into this study.
Dr William Peters, Medical Director of Sunshine Heart, said “The patient is doing well and has suffered no adverse events of any kind. In this patient the C-Pulse generated significantly improved blood flow to the heart muscle and unloaded the heart. These are the effects that we expected to see and, if sustained over a long period, we would expect to see a significant improvement in the patient’s quality of life as a result”
Dr Peters also commented “This placement of the C-Pulse has shown that the clinical team at Auckland City Hospital are ready to undertake the long term human clinical trial. The implantation demonstrated the simplicity of placing the device – unlike blood contacting heart assist devices, the heart-lung machine was not required, the implant took approximately 15 minutes, the device performed as expected and it was able to be turned on and off without complication.” Investigators at Auckland City Hospital are currently seeking suitable patients for the long-term implant study, as well as continuing to enrol patients into the short-term study