VasoHealthcare Holds Launch Summit 2010 In Greensboro, NC

Vasomedical Releases iPhone Application for EECP^® Therapy

Vasomedical Announces Reorganization of Its Board of Directors

Vaso Healthcare, a Subsidiary of Vasomedical, Inc. Signs Exclusive Sales Representative Agreement with GE Healthcare

Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System

More >>

Indications

Enhanced external counterpulsation (EECP®) therapeutic systems are Food and Drug Administration (FDA) cleared noninvasive medical devices for the treatment of patients suffering from stable and unstable angina, congestive heart failure, acute myocardial infarction, and cardiogenic shock. EECP is an evidence-based therapy with more than 150 published papers demonstrating increase in cardiac output, blood flow velocity, circulation and pressure gradient across stenosis to recruit collaterals. EECP® also increases shear stress on the endothelium, improves endothelial function, reduces circulating inflammatory markers and arterial stiffness, and inhibits smooth muscle cell proliferation and migration. It has been demonstrated to be safe and effective in the treatment of angina pectoris as well as chronic heart failure. Since 1999, the Centers for Medicare and Medicaid Services (CMS) and other third-party insurance payers have been providing reimbursement for the treatment of angina symptoms in patients who have been diagnosed with disabling angina (Class III or Class IV Canadian Cardiovascular Society (CCS) classification or equivalent classification, who are not readily amenable to surgical intervention, such as PCI or cardiac bypass. Patients with severe, diffuse coronary atherosclerosis and persistent angina, or significant silent ischemia burden, in whom coronary revascularization has been unsuccessful or incomplete, and symptomatic patients at high risk of adverse events related to invasive revascularization, such as elderly patients and those with diabetes, challenging coronary anatomies, debilitating heart failure, renal failure, or pulmonary disease, have also been shown to derive benefit from EECP® therapy. EECP® therapy has also been shown to be effective in relieving angina symptoms in patients with cardiac syndrome X (microvascular angina). Benefits of EECP® therapy have also been demonstrated in the management of angina in the elderly, angina patients with left main disease, and in patients with mild refractory angina (CCS Class II). EECP® therapy is equally effective in reducing angina symptoms in patients with or without diabetes, and in patients with all ranges of body mass index. EECP® therapy has also been shown to improve exercise capacity in heart failure patients with New York Heart Association (NYHA) Class II/III, and exercise peak oxygen consumption in older patients with heart failure. EECP® therapy has also been demonstrated to be equally effective in providing symptomatic benefits in angina patients with either systolic or diastolic heart failure. The beneficial effects of EECP® therapy have been shown to be sustained at three-year follow-up including patients with left ventricular dysfunction.

Contraindications

According to current FDA labeling, EECP® therapy systems should not be used for treating patients with:

• Arrhythmias that interfere with machine triggering
• Bleeding diathesis
• Active thrombophlebitis
• Severe lower extremity vaso-occlusive disease
• Presence of a documented aortic aneurysm requiring surgical repair
• Pregnancy

Precautions

• Patients with blood pressure higher than 180/110 mmHg should be controlled prior to treatment.
• Patients with a heart rate greater than 120 bpm should be controlled prior to treatment.
• Patients at high risk of complications from increased venous return should be carefully chosen and monitored during treatment. Decreasing cardiac afterload by optimizing diastolic augmentation may help minimize increased cardiac filling pressures due to venous return.
• Patients with clinically significant valvular disease should be carefully chosen and monitored during treatment.
• Certain valve conditions, such as significant aortic insufficiency, or severe mitral or aortic stenosis, may prevent the patient from obtaining benefit from diastolic augmentation and reduce cardiac afterload in the presence of increased venous return.

Special Clinical Issues

• Elderly patients: Patients age 80 years or older can be effectively treated with EECP® therapy.
• Data shows a minimum of one class reduction in angina class and an improvement in quality of life in 76% of patients.
• At one year follow-up, 81% reported maintenance of angina improvement.
• Diabetes: CAD patients with diabetes can safely and effectively be treated with comparable results to non-diabetic CAD patients.
• Obesity: EECP® treatment is equally safe and effective in patients with a diverse range of body mass index (BMI), including obese patients (BMI > 30 kg.m2) and morbidly obese (BMI > 40 kg.m2).
• Severe peripheral vascular disease: listed as precaution due to inadequate diastolic augmentation may have benefits from EECP® treatment similar to those without PVD.
• The effect of EECP treatment in patients with abdominal aortic aneurysm (AAA) with increased risk of rupture or retrograde thromboembolic events has not been reported in the literature.AAA larger than 4.0 cm should be referred to vascular surgeon for evaluation.
• Atrial fibrillation patients can be treated with EECP® with rate control between 40-100 bpm.
• Patients with pacemakers and defibrillators may undergo EECP® treatment safely and derive clinical benefits with appropriate monitoring.
• A rate-adaptive pacemaker may trigger a paced tachycardia due to patient’s body motion and can be turned off during EECP® treatment.
• Treatment protocol: The 35, one-hour daily treatments are associated with angina reduction and improved exercise tolerance in at least 75% of patients.
• Extension of therapy by 10-12 hours is associated with further improvement.
• Repeat treatment: 18% of patients undergo another course of treatment due to recurrent, persistent angina within two years after initial EECP® treatment, with benefits similar to patients who respond to their first course of treatment.