EluPro Antibiotic-Eluting BioEnvelope Registry

Summary

A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation

Eligibility

Inclusion Criteria:

* Patient is undergoing implantation of EluPro with either a de novo CIED implantation or 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, or endovascular 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 into EluPro, preventing closure of the bioenvelope to secure the CIED.
* Patient is currently on chronic immunosuppressive agents or ≥20mg/day of Prednisone or equivalent.
* Patient has known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to the implantation of EluPro.
* Patient is participating in another clinical study that could impact the outcome and documented pre-approval from the study sponsor has not been obtained.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure.

Conditions2

Locations4 sites

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