NEW YORK (
) -- Heart failure is a major medical problem in this country affecting well over five million Americans. However, the development of new and effective heart-failure therapies has lagged for the past several decades.
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is developing a new heart-assist device to treat patients with later stage (class 3 and early class 4) heart failure who fall between the cracks of current therapy. These are typically patients who no longer respond to drug therapy but are too healthy to be considered for transplant or an implanted ventricular assist device i.e. "mechanical heart."
Currently, when drug therapy ceases to be effective, heart-failure patients are fitted with a pacemaker or implantable defibrillator. These devices are considered stopgap treatments because all they do is prevent arrhythmias but don't improve a patient's condition. In fact, the shocks delivered by the devices can actually cause further heart damage over the long term.
Sunshine Heart's C-Pulse Heart system assists the heart in pumping blood through the left ventricle using a proven balloon counter-pulsation technique. A cuff is placed around the outside of the aorta and is attached to a sensing lead that detects when the heart's electrical signal. When the heart is pumping blood, the cuff inflates to increase blood flow. When the cuff deflates, the pumping required by the left side of the heart is decreased. C-Pulse reduces the workload of a patient's heart and increases blood flow through the arteries.
And since the cuff is placed around the outside of the aorta, the risk of infection and stroke is significantly reduced. Patients are not required to take blood-thinning drugs due to C-Pulse.
In a feasibility study of 20 patients using the C-Pulse system, 50% of heart failure patients improved after 12 months, achieving an average reduction in heart-disease classification of over 1 class. The mean improvement in the six-minute walk test was over 50 meters. One patient completely disconnected from the device because he no longer had any symptoms of heart disease. Another patient died due to aortic disruption.
Sunshine Heart is targeted a large commercial market with the C-Pulse system. More than 5 million patients are diagnosed with heart failure in the U.S., with 10% of these patients class III or ambulatory Class IV making them eligible for the C-Pulse.