The Ohio State University Medical Center Implants Two Patients with Sunshine Heart's C-Pulse(TM) Heart Assist System Under FDA-Approved Clinical Trial
SYDNEY, and TUSTIN, Calif., April 21 /PRNewswire/ -- Sunshine Heart , a global medical device company focused on innovative heart assist technologies, announced today that The Ohio State University Medical Center in Columbus, Ohio has successfully completed the first two implants of the Company's C-Pulse(TM) heart assist system under a 20 person clinical trial approved by the U.S. Food and Drug Administration (FDA).
These C-Pulse systems were implanted by Dr. Benjamin Sun, Chief, Division of Cardiothoracic Surgery and Director, Cardiac Transplantation and Mechanical Support.
"It is an honor to have completed the first U.S. implants of the C-Pulse heart assist system," said Dr. Sun. "C-Pulse is highly innovative and implanted with a simple, low-risk minimally invasive surgical procedure. The device has the potential to offer a new therapy option for the treatment of moderate heart failure."
"We are excited that our clinical trial in the U.S. has started so successfully," said Dr. William Peters, Medical Director of Sunshine Heart and the inventor of C-Pulse. "We have demonstrated in prior clinical studies that the C-Pulse system increases blood flow to the body and to the heart muscle itself. We anticipate that C-Pulse will offer patients a significant improvement in quality of life." Dr. Peters went on to point out importantly that the device operates without coming into direct contact with the blood, so avoiding potential complications with systems that do contact blood. A feature of the design of the C-Pulse is that patients can safely disconnect from the device for short periods for their convenience."
"The completion of the initial C-Pulse implants in the U.S. is a major milestone for Sunshine 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, lifestyle adjustments, family education, device therapy (i.e. heart failure pacemaker with or without a defibrillator), or surgery. A major medical treatment challenge is that the medical regimen and CRT options often stop alleviating symptoms over time, hence the need for C-Pulse heart assist.
About Sunshine Heart
Sunshine Heart (www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse(TM) 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 workload. The Company has received approval from the U.S. Food and Drug Administration (FDA) to conduct a 20 person U.S. feasibility clinical trial with C-Pulse and patient enrolment and implants have commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.
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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.
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