Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

Exclusion Criteria

• •1. Emergency cases;
• •2. Re-do cardiac surgery procedure;
• •3. Diabetes mellitus;
• •4. Hematologic diseases or history of thrombophilia;
• •5. Pregnancy or breastfeeding;
• •6. Concomitant major cardiac procedures;
• •7. Active malignant/metastatic neoplasm of any type;
• •8. Presence of pneumothorax and/or pulmonary emphysema;
• •9. Significant central nervous system injury;
• •10. Current intracranial hemorrhage;
• •11. Immunosuppression;
• •12. Contraindication for therapeutic anticoagulation (e.g., heparin);
• •13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
• •14. Abnormal or pathological cannulation site;
• •15. Uncontrolled active bleeding;
• •16. Awaiting transplantation;
• •17. Requiring preoperative extracorporeal membrane oxygenation;
• •18. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.
• •19. Patient is taking part in another interventional clinical study;
• •20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.