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Sunshine Heart - First implant at University of Alabama Medical Centre
22 / 12 / 2009
First implant at University of Alabama
Sunshine Heart, Inc. (ASX: SHC), a global medical device company focused on innovative technologies for advanced heart failure, announced today that the University of Alabama Medical Centre, Birmingham successfully completed an implant of the C-PulseTM heart assist system in a patient under the Company’s US Food and Drug Administration (FDA) approved Phase I clinical trial protocol. This patient is the first patient implanted at the University of Alabama Medical Centre and the fifth patient to be treated with the C-Pulse heart assist system.
Dr. Salpy Pamboukian, Associate Professor of Medicine and Medical Director of the Mechanical Circulatory Support Device (MCSD) Program at the University of Alabama Medical Centre stated, "Our first experience with the C-pulse device has been very positive. Even in the early phase of our patient's recovery, he reported improvement in symptoms and functional capacity and was successfully weaned off inotropic support. I am encouraged by these results and am excited to be able to offer this option to our patients. I believe this will be an important addition to the spectrum of mechanical circulatory support devices available to those affected by refractory advanced heart failure."
Site Expansion
Newly appointed CEO Dave Rosa announced that the Company would be expanding the number of sites implanting the C-Pulse and plans to include Centres in Australia. Rosa commented, “although we are still early in our trial, we are encouraged by the feedback we have received from our current sites and are keen to support some additional Centres that have expressed an interest in participating.” The Company anticipates that these Centres will have their hospital approval to begin implants sometime in the first quarter of 2010.
The current approved sites are: Northwestern Memorial Hospital, The Ohio State Medical Centre, Jewish Hospital, Hershey Medical Centre of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama Birmingham Medical Centre.
Company Update
Rosa also provided an update on the Company’s activities since his appointment.
”Sunshine Heart remains focused on completing the current Phase I study,” he said. “In addition, we are evaluating near term technology improvements that could facilitate a minimally invasive surgical procedure. Implanting the C-Pulse is already much less invasive than traditional ventricular assist device (VAD) operations. Our vision is to offer
the medical community and patients a best practice, minimally invasive therapy for Class III heart failure that maintains or improves the patient’s current medical condition. The goal should be to prevent patients from deteriorating to Class IV heart failure, which typically requires a heart transplant, often preceded by implanting a VAD. Most people with Class III heart failure progress towards Class IV which significantly reduces their life style and their life expectancy. We believe the C-Pulse can at least maintain a patient’s present condition and, in many cases, improve it. If we demonstrate this, suitable patients may not need to undergo higher risk VAD or transplant procedures.
Looking to the future, Rosa went on; “The C-PulseTM addresses a large part of the Class III heart failure market. We are investigating potential synergies with existing, established Class III heart failure therapies to determine if it is possible to provide even more effective patient treatment. We will provide information on progress in this area as it develops.”
Rosa also announced the hiring of Debra Kridner to take charge of Clinical Research and Regulatory Affairs. She previously was Vice President at St Jude Medical Cardiovascular Division in this area. She has held similar positions at Medtronic Inc. and Edwards Lifesciences. “Debra brings a wealth of experience in the clinical and regulatory functions, especially in the areas of cardiac surgery and interventional cardiology. I am pleased she has joined our team and expect great contributions from her.”
Rosa also announced the promotion of Rowena Hubble to the position of Chief Financial Officer, effective immediately. “Rowena has been a key contributor to Sunshine Heart and, during our recent capital raising, she clearly demonstrated her capabilities. Her promotion recognizes this and expands her role.”
About Sunshine Heart
Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse™ an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20 person US clinical trial with C-Pulse and patient enrolment has commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.
For further information, please visit www.sunshineheart.com or contact:
Contact:
Dave Rosa
CEO
+1 [952 ] 237 7412
dave.rosa@sunshineheart.com
Rowena Hubble
Company Secretary
+61 2 8424 7700
rowena.hubble@sunshineheart.com
This press release may contain forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Securities Exchange.
Sunshine Heart, Inc. (ASX: SHC), a global medical device company focused on innovative technologies for advanced heart failure, announced today that the University of Alabama Medical Centre, Birmingham successfully completed an implant of the C-PulseTM heart assist system in a patient under the Company’s US Food and Drug Administration (FDA) approved Phase I clinical trial protocol. This patient is the first patient implanted at the University of Alabama Medical Centre and the fifth patient to be treated with the C-Pulse heart assist system.
Dr. Salpy Pamboukian, Associate Professor of Medicine and Medical Director of the Mechanical Circulatory Support Device (MCSD) Program at the University of Alabama Medical Centre stated, "Our first experience with the C-pulse device has been very positive. Even in the early phase of our patient's recovery, he reported improvement in symptoms and functional capacity and was successfully weaned off inotropic support. I am encouraged by these results and am excited to be able to offer this option to our patients. I believe this will be an important addition to the spectrum of mechanical circulatory support devices available to those affected by refractory advanced heart failure."
Site Expansion
Newly appointed CEO Dave Rosa announced that the Company would be expanding the number of sites implanting the C-Pulse and plans to include Centres in Australia. Rosa commented, “although we are still early in our trial, we are encouraged by the feedback we have received from our current sites and are keen to support some additional Centres that have expressed an interest in participating.” The Company anticipates that these Centres will have their hospital approval to begin implants sometime in the first quarter of 2010.
The current approved sites are: Northwestern Memorial Hospital, The Ohio State Medical Centre, Jewish Hospital, Hershey Medical Centre of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama Birmingham Medical Centre.
Company Update
Rosa also provided an update on the Company’s activities since his appointment.
”Sunshine Heart remains focused on completing the current Phase I study,” he said. “In addition, we are evaluating near term technology improvements that could facilitate a minimally invasive surgical procedure. Implanting the C-Pulse is already much less invasive than traditional ventricular assist device (VAD) operations. Our vision is to offer
the medical community and patients a best practice, minimally invasive therapy for Class III heart failure that maintains or improves the patient’s current medical condition. The goal should be to prevent patients from deteriorating to Class IV heart failure, which typically requires a heart transplant, often preceded by implanting a VAD. Most people with Class III heart failure progress towards Class IV which significantly reduces their life style and their life expectancy. We believe the C-Pulse can at least maintain a patient’s present condition and, in many cases, improve it. If we demonstrate this, suitable patients may not need to undergo higher risk VAD or transplant procedures.
Looking to the future, Rosa went on; “The C-PulseTM addresses a large part of the Class III heart failure market. We are investigating potential synergies with existing, established Class III heart failure therapies to determine if it is possible to provide even more effective patient treatment. We will provide information on progress in this area as it develops.”
Rosa also announced the hiring of Debra Kridner to take charge of Clinical Research and Regulatory Affairs. She previously was Vice President at St Jude Medical Cardiovascular Division in this area. She has held similar positions at Medtronic Inc. and Edwards Lifesciences. “Debra brings a wealth of experience in the clinical and regulatory functions, especially in the areas of cardiac surgery and interventional cardiology. I am pleased she has joined our team and expect great contributions from her.”
Rosa also announced the promotion of Rowena Hubble to the position of Chief Financial Officer, effective immediately. “Rowena has been a key contributor to Sunshine Heart and, during our recent capital raising, she clearly demonstrated her capabilities. Her promotion recognizes this and expands her role.”
About Sunshine Heart
Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse™ an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20 person US clinical trial with C-Pulse and patient enrolment has commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.
For further information, please visit www.sunshineheart.com or contact:
Contact:
Dave Rosa
CEO
+1 [952 ] 237 7412
dave.rosa@sunshineheart.com
Rowena Hubble
Company Secretary
+61 2 8424 7700
rowena.hubble@sunshineheart.com
This press release may contain forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Securities Exchange.