Despite optimal medical therapy and invasive procedures, such as angioplasty or cardiac bypass surgery, many patients still experience angina (chest pain, shortness of breath, fatigue) from their coronary artery disease. Daily tasks that most people take for granted such as climbing a flight of stairs, walking a dog or mowing the lawn become impossible without experiencing chest pain. For these difficult-to-treat patients, the only option is to significantly curtail daily activities in order to avoid the angina symptoms.

In addition, despite advances in medical therapy for the treatment of congestive heart failure (CHF) over the past decade, substantial unmet needs remain, particularly in patients with moderate to severe CHF. Heart failure is a progressive debilitating condition where the heart is unable to pump enough blood throughout the body. Heart failure develops over time, as the pumping action of the heart grows weaker. Patients with mild heart failure today usually progress to moderate or severe heart failure over time. Heart failure is the number one diagnosis in Medicare patients and is the leading cause of hospitalization in patients over the age of 65. CHF also places an enormous burden on the U.S. healthcare system, with an estimated economic impact ranging from $20 billion to in excess of $50 billion per year. Compounding the problem is that there are few consensus therapies to treat CHF beyond "medical management" and many patients now are left to suffer their symptoms chronically and anticipate a reduced life expectancy.

As healthcare costs continue to rise throughout the United States, providers, payers and patients are looking for the most cost-effective options for treating cardiovascular diseases. For patients who are good candidates for the treatment, EECP therapy is considered a safe, highly beneficial, low cost, non-invasive therapy.

Vasomedical’s advanced EECP therapy systems utilize fundamental hemodynamic principles to augment coronary blood flow, reduce the workload of the heart and improve overall vascular function. The treatment is completely non-invasive and is administered to patients on an outpatient basis, usually in daily one-hour sessions, five days per week over seven weeks for a total of 35 treatments. The procedure is well tolerated and patients may begin to experience relief of chest pain after 15 to 20 hours of therapy. Positive effects have been shown in most patients to continue for years following a full course of therapy.

More than 800 physicians in the U.S. use EECP therapy to treat approximately 19,000 patients annually who suffer with chronic angina and heart failure. With a success rate of approximately 80 percent and an annual growth rate of over 30 percent, EECP therapy is one of the fastest-growing medical procedures in the country. More than 80 articles published in leading medical journals document significant benefits to patients suffering from angina and congestive heart failure, including symptom relief, increase in functional capacity and

improved quality of life.

During EECP therapy, the patient lies on a treatment table while wearing three sets of inflatable pressure cuffs—resembling oversized blood pressure cuffs—on the calves, the lower and upper thighs, including the buttocks. The cuffs inflate rapidly and sequentially—via computer-interpreted electrocardiogram (ECG) signals—starting from the calves and proceeding upward to the buttocks during the resting phase of each heartbeat (diastole). This has the effect of creating a strong retrograde counter pulse in the arterial system,

forcing freshly oxygenated blood towards the heart and coronary arteries, while simultaneously increasing the volume of venous blood return to the heart under increased pressure.

Just prior to the next heartbeat, before the heart begins to eject blood by contracting (systole), all three cuffs simultaneously deflate, significantly reducing the workload of the heart. This is achieved because the vascular

beds in the lower extremities are relatively empty when the cuffs are deflated, significantly lowering the resistance to blood ejected by the heart, reducing the amount of work the heart must do to pump oxygenated blood to the rest of the body.

The inflation/deflation activity is monitored constantly and coordinated by a microprocessor that interprets ECG signals from the patient's heart, monitors heart rhythm and rate information and actuates the inflation and deflation cycles. The end result of this sequential "squeezing" of the legs is to create a pressure wave that significantly increases peak diastolic pressure, benefiting circulation to the heart muscle and other organs, while also reducing systolic pressure and systemic vascular resistance to the general benefit of the vascular system.

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Patients wear special pants during the treatment to minimize the possibility of skin irritation. During therapy the therapist often elects to educate or reinforce prior instructions to the patients such as providing information about their specific condition, the advantages of exercise for general well being, maintaining the benefits of EECP therapy, proper diet, limiting alcohol consumption, smoking cessation and proper adherence to medication regimens.

While the exact mechanism whereby EECP therapy produces clinical improvement remains unknown, there are several hypothesized mechanisms of action for EECP that have been discussed in clinical literature and include: