Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.

The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.

Inclusion Criteria:

• The patient must be equal or greater than 18 years old
• The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
• The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
• The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
• The patient must provide written informed consent using a form that is reviewed and approved by the IEC

Exclusion Criteria:

• The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
• The patient has a known hypersensitivity to materials of bovine origin
• The patient does not wish to receive materials of bovine or shellfish origin for any reason