The C-Pulse Heart Assist System is a therapeutic new approach under an FDA approved feasibility IDE for the rapidly growing heart failure market, which is the leading cause of hospitalization in the United States. The total costs to the United States healthcare system are more than $33 billion annually. In addition to the more than 5 million cases of heart failure in the U.S. (approximately 33 million worldwide), the incidence is accelerating at such an alarming rate that the U.S. National Heart, Lung and Blood Institute has characterized it as a "new epidemic."
Compounding the challenge of treating heart failure (HF) is the condition's progressive nature, which causes patients' symptoms to worsen over time. Drug therapy is prescribed for many HF patients to relieve symptoms and enable them to maintain their quality of life. The progression of a patients’ heart failure may be categorized according to the New York Heart Association (NYHA) as Class I through Class IV.
As a patients' HF progresses, drug therapy may become less effective. When a patient is unable to perform daily activities or mild exercise without experiencing HF symptoms, they may be classified as NYHA Class III, otherwise known as moderate HF. Today, Class III patients with ventricular dysynchrony may receive pacemaker therapy known as cardiac resynchronization therapy (CRT's are a $3 billion US market). Twenty-five percent of these patients will not demonstrate any improvement and an additional twenty-five percent will demonstrate only marginal improvement. This leaves a large number of patients with Class III symptoms with few, if any, therapeutic options.
Patients that are categorized as class IV or end stage heart failure, may require a heart transplant or receive a left ventricular assist device (LVAD). LVAD's are approaching a $400 million dollar market in the U.S.