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ASX Announcement - Clinical Trial Update
01 / 09 / 2005
Sydney, Australia: Sunshine Heart, Inc., (ASX: SHC) today provided an update on the C-Pulse device recently implanted in a New Zealand patient. The device was successfully implanted, the patient left hospital after only 9 days and showed very positive progress at one month. The patient has now suffered an infection of the device which has now been removed. The Patient is in a stable condition recovering in hospital following the operation.
Dr Paget Milsom, Head of Cardiothoracic Surgery, who is the principal surgical investigator in the trial of the C-Pulse device commented "This patient had initially been accepted for cardiac transplantation but over time his condition had deteriated and he was no longer suitable for heart transplant. He was very sick at the time of placement of the C-Pulse device. He tolerated the operation well and was released from the hospital after 9 days. By one month improvement in the objective measures of cardiac performance and quality of life were seen, to the extent that his functional classification had reduced from Class IV to Class III plus there was a significant improvement in the distance he was able to walk.
Unfortunately, while at home, the patient noticed an infective discharge around the C-Pulse driveline. It was in the patient's best interests to remove the device. This was undertaken successfully. The patient is now recovering in the hospital."
Sunshine Heart Inc. Medical Director, Dr William Peters, said "Device infections are an unfortunate, but inherent, event associated with implanted medical devices. Although it is unfortunate that the patient suffered from this all too common an event, which occurs in up to 38% of cases, it is pleasing to note that the C-Pulse device was able to be removed safely from the patient. This is in contrast to the experience of many of these patients, with ventricular assist devices, where removal of the device is not possible."
The clinical trial is continuing and potential patients are currently being screened at Auckland City Hospital.
More information about the C-Pulse heart assist device may be obtained at www.sunshineheart.com
For further information, please contact:
Media
Rebecca Christie
+61 2 9293 2836 / 0417 382 391
rchristie@bcg.com.au
Sunshine Heart
Crispin Marsh
Director of Corporate Affairs
+61 2 9818 7913
crispin.marsh@sunshineheart.com
or
Don Rohrbaugh
CEO
+1 714 665 1951
don.rohrbaugh@sunshineheart.com
Dr Paget Milsom, Head of Cardiothoracic Surgery, who is the principal surgical investigator in the trial of the C-Pulse device commented "This patient had initially been accepted for cardiac transplantation but over time his condition had deteriated and he was no longer suitable for heart transplant. He was very sick at the time of placement of the C-Pulse device. He tolerated the operation well and was released from the hospital after 9 days. By one month improvement in the objective measures of cardiac performance and quality of life were seen, to the extent that his functional classification had reduced from Class IV to Class III plus there was a significant improvement in the distance he was able to walk.
Unfortunately, while at home, the patient noticed an infective discharge around the C-Pulse driveline. It was in the patient's best interests to remove the device. This was undertaken successfully. The patient is now recovering in the hospital."
Sunshine Heart Inc. Medical Director, Dr William Peters, said "Device infections are an unfortunate, but inherent, event associated with implanted medical devices. Although it is unfortunate that the patient suffered from this all too common an event, which occurs in up to 38% of cases, it is pleasing to note that the C-Pulse device was able to be removed safely from the patient. This is in contrast to the experience of many of these patients, with ventricular assist devices, where removal of the device is not possible."
The clinical trial is continuing and potential patients are currently being screened at Auckland City Hospital.
More information about the C-Pulse heart assist device may be obtained at www.sunshineheart.com
For further information, please contact:
Media
Rebecca Christie
+61 2 9293 2836 / 0417 382 391
rchristie@bcg.com.au
Sunshine Heart
Crispin Marsh
Director of Corporate Affairs
+61 2 9818 7913
crispin.marsh@sunshineheart.com
or
Don Rohrbaugh
CEO
+1 714 665 1951
don.rohrbaugh@sunshineheart.com