This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
Study Type
OBSERVATIONAL
Enrollment
75
German Heart Center
Munich, Germany
San Raffale Hospital
Milan, Italy
Achievement of haemostasis
Time frame: 3 minutes after application
Time to haemostasis
Time frame: measured through to 10 minutes
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