SOURCE: Sunshine Heart, Inc.

Sunshine Heart, Inc.

April 03, 2011 19:00 ET

Sunshine Heart Announces Completion of Enrollment of 20 Patients for C-Pulse® Heart Assist System

Twenty Patients Successfully Implanted With Unique Heart Failure Treatment Device

MINNEAPOLIS, MN--(Marketwire - April 3, 2011) - Sunshine Heart, Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that its C-Pulse® Heart Assist System has been implanted in 20 patients globally as of March 31, 2011. The C-Pulse studies are primarily designed to assess safety and provide indications of performance of this device in Class III/ambulatory Class IV (moderate to severe) heart failure patients suffering from symptoms such as shortness of breath and reduced mobility.

"Completing enrollment of 20 patients represents Sunshine Heart's most historic milestone to date," said Dave Rosa, Sunshine Heart's CEO. "We wish to thank all of our investigators and their teams for their support. In addition, I am also pleased to announce that we remain on target to achieve a number of additional critical milestones in the calendar year and look forward to sharing our exciting progress."

Using intra-aortic balloon counter-pulsation technology, the C-Pulse Heart Assist System assists 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 Heart Assist System offers the potential to treat patients with moderate to severe heart failure who, despite the best available treatments, remain substantially disabled," said Dr. William Abraham, Chief, Division of Cardiovascular Medicine at Ohio State University. "C-Pulse addresses some of the fundamental aspects of heart failure, notably low cardiac output, poor peripheral perfusion, and inadequate blood flow to the coronary arteries."

The C-Pulse System is an earlier intervention than other mechanical therapies, such as LVADs. This device does not directly contact the patient's blood and it may be turned on or off at any time allowing the patient intervals of freedom to perform certain activities. The C-Pulse System may also be implanted via a minimally invasive procedure, which may reduce procedural time, hospital stays, overall cost and patient risk as compared to a traditional sternotomy.

"In addition to its clinical benefits, the C-Pulse system, in comparison to other devices used for circulatory support, also offers the advantage of implantation through a small, pacemaker-like incision between the ribs, without the need for sternal division or the use of cardiopulmonary bypass," said Sanjeev Aggarwal, M.D., Director of Mechanical Circulatory Support at the Mid America Heart and Vascular Institute, Kansas City, Missouri. "This offers the opportunity to provide patients suffering from heart failure a means of mechanical support using a low-risk, minimally invasive procedure with a very short recovery period."

Sunshine Heart remains on track to meet key regulatory milestones previously advised to the market. The 20 patient FDA-approved IDE feasibility 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 with the C-Pulse System at specified intervals to assess safety and potential benefits. After six-month follow-up with the 20th patient, Sunshine Heart will submit the feasibility data to the FDA. Shortly thereafter, the company will seek FDA approval for the pivotal trial protocol.

About the C-Pulse Heart Assist System
The C-Pulse Heart Assist System uses proven balloon counter-pulsation 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 invasive 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) is a global medical device company committed to the commercialization of the C-Pulse® Heart Assist System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure which can be implanted using a minimally invasive procedure. C-Pulse is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology by enabling 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 to conduct a 20-patient U.S. feasibility clinical trial with the C-Pulse System. Sunshine Heart is a Delaware-based corporation headquartered in Minneapolis, MN, 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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