TYRX™ Pocket Health Study

Exclusion Criteria

• •2. Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment
• •3. Procedure information from participant's TYRX procedure of interest can be obtained
• •1. Date of the TYRX procedure of interest
• •2. Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest
• •4. Provides signed and dated authorization and/or consent per institution and local requirements
• •5. Willing and able to comply with the protocol
• •1. Active infection involving the CIED implant site (physical, clinical, or laboratory signs/symptoms consistent with an active infection at time of replacement procedure, including but not limited to pneumonia, urinary tract, cellulitis, endocarditis, or bacteremia)
• •2. Prior history of requiring invasive intervention to the pocket since the TYRX procedure of interest, including but not limited to lead revisions or CIED infection
• •3. Prior history of skin infection at CIED implant site since the TYRX procedure of interest
• •4. Returning for a CIED extraction, system upgrade, CIED replacement with planned lead addition and/or revision, planned lead revision, or pocket revision (e.g., pocket revision due to pain)
• •5. Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD)
• •6. Existing Ventricular Assist Device (VAD)
• •7. Currently receiving hemodialysis or peritoneal dialysis therapy
• •8. Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone (or equivalent)
• •9. Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED)
• •10. Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence
• •11. Legally incompetent or otherwise vulnerable
• •12. Participation in another study that may potentially confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic