News & Events
< Back to News Overview
Update on Clinical Trial Program
29 / 07 / 2005
Sydney, Australia - Medical investigators at Auckland City Hospital today provided an update on the long-term pilot clinical trial of Sunshine Heart's (ASX: SHC) C-Pulse heart assist device.
Sadly, the first patient who received the C-Pulse device on May 04, 2005 died eleven and a half weeks after implant due to multi-organ failure unconnected with the C-Pulse device. This patient had a 15-year history of heart failure, with concomitant diabetes in addition to chronic kidney and liver failure. He had been assessed as not suitable for heart transplantation. He endured nine hospital admissions in the 18 months prior to implantation of the C-Pulse. Sunshine Heart reported in May that the operation to implant the device was successful, and the patient was subsequently discharged home with the device performing well. No device-related complications such as stroke, infection, bleeding, re-operation or device failure were observed thoughout the follow-up period of nearly three months.
Chief investigative surgeon, Dr Paget Milsom, said: "While it is unfortunate to lose any patient, the autopsy confirms that the patient's death was unconnected with the C-Pulse device. Prior to his death, the patient reported that the device made his breathing easier. We are continuing the process of implanting further C-Pulse devices in suitable patients in the pilot study".
Dr William Peters, Medical Director of Sunshine Heart Inc, explained: "This study is designed to primarily test the safety of the C-Pulse device in the treatment of heart failure. Such trials necessarily start with very sick patients. It is only through this process that the medical community can gain the confidence to use new procedures and devices in less sick patients. The device has shown itself to be able to be safely implanted without the need for the heart-lung machine, and that it provided counterpulsation support to the heart for nearly 3 months without any device-related complications."
More information about the C-Pulse heart assist device may be obtained at www.sunshineheart.com.
Sadly, the first patient who received the C-Pulse device on May 04, 2005 died eleven and a half weeks after implant due to multi-organ failure unconnected with the C-Pulse device. This patient had a 15-year history of heart failure, with concomitant diabetes in addition to chronic kidney and liver failure. He had been assessed as not suitable for heart transplantation. He endured nine hospital admissions in the 18 months prior to implantation of the C-Pulse. Sunshine Heart reported in May that the operation to implant the device was successful, and the patient was subsequently discharged home with the device performing well. No device-related complications such as stroke, infection, bleeding, re-operation or device failure were observed thoughout the follow-up period of nearly three months.
Chief investigative surgeon, Dr Paget Milsom, said: "While it is unfortunate to lose any patient, the autopsy confirms that the patient's death was unconnected with the C-Pulse device. Prior to his death, the patient reported that the device made his breathing easier. We are continuing the process of implanting further C-Pulse devices in suitable patients in the pilot study".
Dr William Peters, Medical Director of Sunshine Heart Inc, explained: "This study is designed to primarily test the safety of the C-Pulse device in the treatment of heart failure. Such trials necessarily start with very sick patients. It is only through this process that the medical community can gain the confidence to use new procedures and devices in less sick patients. The device has shown itself to be able to be safely implanted without the need for the heart-lung machine, and that it provided counterpulsation support to the heart for nearly 3 months without any device-related complications."
More information about the C-Pulse heart assist device may be obtained at www.sunshineheart.com.