Progel Vascular Sealant

Exclusion Criteria

• •1\. Subject has Type A or other acute thoracic aortic dissection.
• •2\. Subject has undergone prior thoracic surgery (open thoracotomy not including interventional cardiology procedures).
• •3\. Subject is undergoing a planned concomitant procedure other than coronary artery bypass graft (CABG).
• •4\. Subject has a previous organ transplant.
• •5\. Subject has known or suspected preoperative coagulation disorder.
• •6\. Subject is allergic to human thrombin or has a history of allergic reactions after application of human thrombin.
• •7\. Subject is allergic to protamine.
• •8\. Subject has a Left Ventricular Assist Device (LVAD) or planned to receive an LVAD.
• •9\. Subject is undergoing emergency surgery.
• •10\. Subject is in chronic renal failure.
• •11\. Subject has a hematocrit \< 21% pre-operatively.
• •12\. Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
• •13\. Subject has a cardiac ejection fraction \<25%.
• •14\. Subject is scheduled for another cardiac surgery within 30 days of enrollment.
• •15\. Subject has an active or latent infection which is systemic or at the intended surgery site.
• •16\. Subject is immuno-compromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders.
• •17\. Subject is pregnant by a positive pregnancy test or has plans to become pregnant during the study period or is currently breast-feeding.
• •18\. Subject is unwilling to receive blood products.
• •19\. Subject has participated in another investigational research study within 30 days of enrollment.
• •20\. In the opinion of the investigator, the subject has a clinical condition that would preclude the use of the study device, preclude the subject from completing the follow-up requirements, or would complicate the evaluation of this study.