Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation

Exclusion Criteria

• •1. Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
• •2. Participants under the age of 18 at time of enrollment.
• •3. Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded:
• •1. CanGaroo® envelope → TYRX™ envelope
• •2. TYRX™ envelope → CanGaroo® envelope
• •3. CanGaroo® envelope - no envelope
• •4. TYRX™ envelope → no envelope
• •5. No envelope → CanGaroo® envelope → no envelope
• •6. No envelope → TYRX™ envelope → no envelope
• •7. No envelope → CanGaroo® envelope → TYRX™ envelope
• •8. No envelope → TYRX™ envelope → CanGaroo® envelope
• •9. CanGaroo® envelope → no envelope → TYRX™ envelope
• •10. TYRX™ envelope → no envelope → CanGaroo® envelope
• •11. CanGaroo® envelope → TYRX™ envelope → no envelope
• •12. TYRX™ envelope → CanGaroo® envelope → no envelope
• •13. CanGaroo® envelope → CanGaroo® envelope → no envelope
• •14. TYRX™ envelope → TYRX™ envelope → no envelope
• •4. Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.