|By Marketwired .||
|September 29, 2010 08:00 AM EDT||
EDEN PRAIRIE, MN -- (Marketwire) -- 09/29/10 -- Sunshine Heart Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that it has engaged two leading industrial design and software firms to develop the next generation electronic power and software driver for its C-Pulse® Heart Assist System. By miniaturizing the separately-housed controller and driver and combining them into one compact unit, Sunshine Heart is broadening future clinical and commercialization opportunities for C-Pulse.
The Company has entered joint development programs to develop a smaller, quieter and lighter single-control system for use in the U.S. pivotal clinical trial, which is expected to commence once the FDA approved IDE feasibility study is completed. The new C-Pulse design will integrate the power driver and battery pack into one unit, significantly reducing the size and the weight of external components. These external design changes will greatly improve mobility and comfort for the patient without altering C-Pulse implantable components or the way in which the device functions inside the body. The new single unit will also feature a number of software enhancements that are intended to allow medical professionals to collect additional data to improve patient management.
Sunshine Heart Chief Executive Officer Dave Rosa said, "Due to its small internal components, the C-Pulse can ideally be implanted through minimally invasive procedures as opposed to a full sternotomy procedure. Now, with the redesign of C-Pulse external components, the system will be more ergonomically appealing and comfortable for patients. Our ultimate goal is to make the C-Pulse a fully-implantable system which, much like a pacemaker, can be easily implanted and effortlessly managed by patients."
Co-principal medical investigator for Sunshine Heart's FDA approved IDE feasibility study, William T. Abraham, MD, Professor of Medicine and Chief of the Division of Cardiovascular Medicine at The Ohio State University Heart Center in Columbus, Ohio, said, "Reducing the size and bulk of the external system combined with a less-invasive surgical procedure will dramatically expand the use of the C-Pulse among physicians. This treatment has the potential to transform the way in which heart failure is treated and I am eager to see this treatment reach more patients."
The C-Pulse heart assist system is designed to treat patients suffering from the debilitating effects of moderate to severe heart failure caused by a failing left ventricle (the left heart chamber). The C-Pulse System features a unique balloon counterpulsation technology that is designed to assist the left ventricle by reducing the workload required to pump blood throughout the body. In addition, it increases blood flow to the coronary arteries. Combined, these potential benefits may help reverse the heart failure process or maintain the patient's current condition, thereby preventing the need for later stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
The C-Pulse System is an earlier intervention than other mechanical therapies, such as LVADs. This device does not make direct contact with patient's blood and it can be turned on or off at any time, allowing patients intervals of freedom to perform certain activities. The C-Pulse System can also be implanted as a minimally invasive procedure, thereby potentially reducing procedural time, hospital stays, overall cost and patient risk as compared to a traditional sternotomy.
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System uses proprietary balloon counterpulsation technology to increase the amount of blood pumped by the heart and to reduce the workload on the heart. The C-Pulse System is implanted in the patient's chest through a sternotomy or through a small incision when performed as a minimally invasively procedure. During the procedure, there is no need to place the patient on a heart-lung machine as the patient's heart remains beating continuously.
Once implanted, the C-Pulse cuff is positioned on the outside of the patient's ascending aorta above the aortic valve. An ECG sense lead is then attached to the heart to determine timing for cuff inflation and deflation in synchronization with the heartbeat. The C-Pulse cuff and lead are connected to a single line that is run through the abdomen to connect to a power driver outside the body. Because the C-Pulse System remains outside the blood system, there is potentially less risk of blood clots and stroke in comparison to other mechanical devices, such as left ventricle assist devices (LVADs).
About Sunshine Heart®
Sunshine Heart® (ASX: SHC) a global medical device company committed to the commercialization of the C-Pulse® Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. C-Pulse® relieves 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 a reduction in the heart's pumping load. The Company has received approval from the U.S. Food and Drug Administration (FDA) to conduct a 20-patient U.S. clinical trial with the C-Pulse® System and the study will reach seventy-five percent enrollment by September 30, 2010. Sunshine Heart is a Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004. For more information, please visit www.sunshineheart.com.
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