Sunshine Heart Inc. (SSH)

Sunshine Heart's C-Pulse® Heart Assist System is an innovative approach to assist the heart's function, not replace it and may be implanted using a minimally invasive approach. The C-Pulse Heart Assist System is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure, sometimes also referred to as moderate and severe failure. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life.

The C-Pulse Heart assist system is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure. These symptoms normally include shortness of breath, dizziness, low blood pressure and fluid retention. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life. The C-Pulse Heart Assist System may be implanted through a minimally invasive or full sternotomy technique. 

The C-Pulse System's design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, theworkload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient's ECG, similar to a pacemaker. Potential benefits of the technology, which are currently being analyzed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac function.

The C-Pulse is designed to improve heart function in three ways:

	More blood flow from the heart called increased cardiac output
	More oxygen to the heart muscle, called increased coronary blood flow
	Less work for the heart, called decreased afterload

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SYDNEY, AUSTRALIA and EDEN PRAIRIE, MN--(Marketwire -06/07/12)- Sunshine Heart, Inc. (SSH) (SHC.AX), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that the company has been granted approval by Health Canada to use its next generation C-Pulse® Heart Assist System driver in ongoing clinical studies at Royal Victoria Hospital. The new C-Pulse driver is designed to provide heart failure patients with enhanced patient comfort and performance. The C-Pulse System is a new investigational therapeutic approach based on proven balloon counter-pulsation technology for the treatment of patients with Class III and ambulatory Class IV heart failure.

 

The C-Pulse driver now comes as a single unit that is half the size, lighter and quieter than the first generation technology. The driver also features a number of software enhancements. The C-Pulse System is currently in an investigational study at Royal Victoria Hospital. The prospective study is designed to evaluate the safety and performance of the C-Pulse System as a treatment for patients with moderate to severe heart failure. To date, four patients have been implanted with the initial C-Pulse System. The company has received Health Canada approval to expand the number of participants in the trial to 20 patients. All trial participants will receive the new C-Pulse driver, which will be used in ongoing and future clinical studies.

 

"We are pleased to have received Health Canada approval of our next generation C-Pulse driver technology for clinical use," said Dave Rosa, CEO of Sunshine Heart. "We enhanced the driver based on results from our feasibility trial and feedback from physicians and patients. With the reduced size, weight and noise reduction, we expect improvements in patient quality of life due to enhanced comfort and performance. We look forward to making this new technology available to patients enrolled in our clinical studies in Canada in the coming weeks, as well the United States and Europe thereafter."

 

The external C-Pulse driver inflates and deflates the balloon which is secured by a cuff around the outside of the ascending aorta, the main blood vessel of the heart. The cuff and heart signal sensing wires are attached to the external C-Pulse driver, which inflates and deflates the balloon in sequence with the electrocardiogram (ECG) signal to assist heart function and the pumping capacity of the heart. The balloon deflects the aorta in a "thumb-printing" manner, which is intended to minimize aortic wall strain and maximize blood volume displacement per beat.

 

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. More than five million people in the United States have heart failure, resulting in more than 300,000 deaths each year(1). Heart failure is a progressive condition and typically results from damage to the heart muscle arising from a heart attack or virus.

 

Cardiologists use the New York Heart Association (NYHA) 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. More than 1.5 million U.S. heart failure patients are in the Class III or moderate heart failure category which is defined by the limitation of physical activity(2). 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. These standard treatments often do not resolve the progression of heart failure leaving patients without any additional options, hence the need for new treatments for patients living with the disease.

 

Caution - Investigational device. Limited by Federal (or United States) law to investigational use.