The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.
Study Type
OBSERVATIONAL
Enrollment
1,025
Proportion of Subjects With ECM Related Adverse Events
ECM related adverse events were collected at all study visits.
Time frame: Participants were followed for an average of 235.0 days.
Number of Participants With Major Pocket Infections
Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
Time frame: Participants were followed for an average of 235.0 days.
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Advanced Cardiovascular, LLC
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