Sunshine Heart Announces First Minimally Invasive Thoracotomy Procedures Performed for the C-Pulse(R) Heart Assist System

MINNEAPOLIS, MN–(Marketwire – August 31, 2010) –  Sunshine Heart Inc., a global medical device company focused on innovative technologies for moderate heart failure, today announced that its C-Pulse^® Heart Assist System has been successfully implanted using a minimally invasive thoracotomy procedure at Saint Luke’s Mid America Heart and Vascular Institute in Kansas City, MO. The C-Pulse System is the first known mechanical heart assist system to be implanted using a minimally invasive thoracotomy technique. The device was inserted through a small, pacemaker-like incision between the patient’s ribs, leaving the sternum intact. To date, thirteen patients have been implanted under Sunshine Heart’s existing worldwide C-Pulse study protocols. The FDA approved IDE feasibility study will include a total of 20 patients to evaluate the performance of this device for patients with moderate heart failure.

The C-Pulse Heart Assist System is designed to treat patients suffering from the debilitating effects of moderate 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. 

“We are pleased to welcome Saint Luke’s Mid America Heart and Vascular Institute to our C-Pulse clinical trial,” said Dave Rosa, CEO of Sunshine Heart. “These latest procedures accomplish our goal of successfully implanting the C-Pulse System through a mini-thoracotomy surgical method. As we approach the end of our feasibility study, we are encouraged by the interest of our centers and we remain dedicated to developing this minimally invasive, cost-effective treatment that is intended to relieve the symptoms of moderate heart failure.”

Sanjeev Aggarwal, MD, Director of Mechanical Circulatory Support at Saint Luke’s Mid America Heart and Vascular Institute in Kansas City, Missouri, performed the procedures. In addition to performing the first minimally invasive thoracotomy C-Pulse procedures, Dr. Aggarwal has also successfully performed a minimally invasive hemi-sternotomy (mini-sternotomy) C-Pulse procedure at St. Luke’s Hospital.

“The C-Pulse Heart Assist System represents an important advance in the treatment of patients suffering from heart failure,” commented Dr. Aggarwal. “In our initial procedure last month, the clinical effects were dramatic, with an almost immediate improvement in cardiac performance and the patient’s functional status. I am very encouraged that we were able to perform our two subsequent implants utilizing a minimally invasive pacemaker-like incision, without dividing the sternum. This offers the opportunity to provide patients suffering from moderate heart failure with a means of mechanical circulatory support through a truly minimally invasive, low risk procedure with a short recovery period.”

“Today, there are few treatment options for the millions of Class III/IVa moderate heart failure patients who have achieved the maximum benefits of drug and pacemaker therapy yet still suffer from symptoms such as shortness of breath and reduced mobility,” said Dr. Andrew Kao, Medical Director of Heart Transplantation at St. Luke’s Mid America Heart Institute. “I am very pleased that the new C-Pulse therapy is being studied at St. Luke’s Hospital as we believe this device can make a tremendous difference for these patients who have limited treatment options.”

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.

Sunshine Heart’s FDA approved IDE study is available to men and women between the ages of 18 to 75 who suffer from Class III/ambulatory Class IV heart failure and for whom standard drug therapy has failed. The study monitors each patient’s performance with the C-Pulse System at one-month, three-month and six-month intervals to assess risks and potential benefits. Each patient’s physical endurance, quality of life and cardiac performance will also be specifically monitored.

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 sensing 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 electrical leads 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 that reside or function in the bloodstream.

About Sunshine Heart
Sunshine Heart (ASX: SHC), a global medical device company focused on innovative technologies for the treatment of moderate heart failure, is commercializing the C-Pulse^® Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. The C-Pulse System 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 US Food and Drug Administration (FDA) to conduct a 20-patient U.S. clinical trial with the C-Pulse^® System and the study has achieved more than fifty percent enrollment as of August 2010. Sunshine Heart, Inc. 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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