INDICATIONS FOR USE

Vasomedical enhanced external counterpulsation therapy systems are noninvasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock.

CONTRAINDICATIONS

§ 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 with enhanced external counterpulsation

§ Patients with a heart rate more than 120 bpm should be controlled prior to treatment with enhanced external counterpulsation

§ Patients at high risk of complications from increased venous return should be carefully chosen and monitored during treatment with enhanced external counterpulsation. 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 with enhanced external counterpulsation. 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 reduced cardiac afterload in the presence of increased venous return.

For further understanding of patient selection criteria please refer to the following publications:

§ Micaels AD, et al. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. Review.

§ Linnemeier G. Enhanced External Counterpulsation - A Therapeutic Option for Patients with Chronic Cardiovascular Problems. Journal of Cardiovascular Management; 2002 Nov-Dec;13(6):20-25.

§ Ochoa A et al. Enhanced External Counterpulsation Therapy: A Noninvasive Approach to Treating Heart Disease. The American Journal of Medicine & Sports. 2003 May/Jun;V(III):194-8.

§ Crawford LE. Experience with Enhanced External Counterpulsation (EECP) in Coronary Artery Disease. Today’s Therapeutic Trends. 2002; 20 (3): 243-252.

§ Lawson WE. Current Use of Enhanced External Counterpulsation and Patient Selection. Clinical Cardiology. 2002 Dec;25(12 Suppl 2):II16-21.