The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
Study Type
OBSERVATIONAL
Enrollment
300
Commercial Evicel
Baptist Health Medical Center
Jacksonville, Florida, United States
Memorial Hospital
Jacksonville, Florida, United States
Specific Safety Parameters
* Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events
Time frame: Up to 4-weeks post-operatively
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