 8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor, significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator. 