EluPro Antibiotic-Eluting BioEnvelope Registry

Inclusion Criteria:

• Patient is undergoing implantation of EluPro with either a de novo CIED implantationor has an existing CIED and is undergoing CIED replacement or upgrade.

• Patient is willing to comply with scheduled follow-up and study-related visits.

• Patient is 18 years of age or older at the time of enrollment.

• Patient agrees to provide written informed consent and use of PHI.

Exclusion Criteria:

• Patient has a prior history of CIED infection, other prosthetic device infection, orendovascular infection, including endocarditis, in the past 12 months.

• Patient is exhibiting signs or symptoms consistent with any type of active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia).

• Patient has Stage 4 or 5 kidney disease (eGFR <30 ml/min).

• Patient requires long-term vascular access for any reason.

• Patient is undergoing implantation of a CIED that does not fit completely intoEluPro, preventing closure of the bioenvelope to secure the CIED.

• Patient is currently on chronic immunosuppressive agents or ≥20mg/day of Prednisoneor equivalent.

• Patient has known allergy to minocycline or rifampin or their derivatives, or anyother known contraindications to the implantation of EluPro.

• Patient is participating in another clinical study that could impact the outcome anddocumented pre-approval from the study sponsor has not been obtained.

• Female patient who is pregnant, or of childbearing potential and not on a reliableform of birth control. Women of childbearing potential are required to have anegative pregnancy test within 7 days prior to device procedure.