Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Patients undergoing cardiac or cardiovascular procedures, including, but not limited to:

Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)

Inclusion Criteria:

• Subject is undergoing an elective cardiac or cardiovascular procedure;
• Subject is willing and able to give prior written informed consent for investigation participation; and
• Subject is > 18 years of age.

Intraoperative inclusion criteria include:

• Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).

Exclusion Criteria:

• • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;

  • Subject with active infection (either systemic or in the repair region);
  • Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
  • Subject diagnosed with a coagulation disorder;
  • Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
  • Subject whose life expectancy is less than that required for the prescribed follow-up duration;
  • Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
  • Subject who is immunocompromised.

Intraoperative exclusion criteria include:

• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).