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First Patients in United States Receive Innovative Device to Treat Moderate Heart Failure
Date:4/21/2009

nshine Heart which is the only non-blood contacting heart assist device in clinical trials," said Don Rohrbaugh, the Company's CEO. "The start of our clinical trial brings us one step closer toward our goal to address the large and growing unmet clinical need for an alternative heart failure treatment to improve and sustain a patient's quality of life." Mr. Rohrbaugh noted, "C-Pulse is designed for Class III heart failure patients and these are defined as suffering continuing debilitating symptoms despite maximum drug therapy."

The 20 patient FDA-approved feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital, The Ohio State Medical Center Jewish Hospital University (University of Louisville), Hershey Medical Center of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama/ Birmingham Medical Center.

About Class III Heart Failure

Heart failure is a common condition in which the heart becomes unable to pump sufficient blood to meet the body's needs. Over five million people in the United States have heart failure and it results in over 300,000 deaths each year. Heart failure is a progressive condition and typically results from damage to the heart muscle arising from a heart attack or virus.

Cardiologists use a classification system to define the four classes of heart failure; each class is determined by rating a patient's symptoms to everyday activities and quality of life. Over 1.4 million US heart failure patients are in the Class III or moderate heart failure category which is defined by the limitation of physical activity. These patients are comfortable at rest, but levels of activity regarded as less than ordinary cause fatigue, palpitation, and/or shortness of breath. The most common treatments for Class III heart failure are drugs, lifesty
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SOURCE Sunshine Heart
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