Bloom et al. PACE 2011;34(2);133-142 

A Multicenter Retrospective Cohort Study of Patients Undergoing CIED Implantation with the AIGISRx Antibacterial Envelope

Purpose: Define rate of A) Successful CIED implantation and B) CIED infection in patients undergoing CIED procedures with AIGISRx.

Study Design: Multicenter, retrospective cohort study. Procedures following an explantation for a prior CIED infection or for off-label indication were excluded from analyses.

• 642 patients enrolled at 10 U.S. academic, community, and VA medical centers with 1.9 +/- 2.4 months follow-up. 624 patients met criteria for analyses.

• > 99% of all CIEDs were successfully implanted.

• CIED infection rate was 0.48% for all procedures, 0.00% for initial procedures, and 0.71% for replacement/revision procedures.

• 60% - 70% fewer infections in highest risk subset of COMMAND Study, ICD/CRT replacement/revisions, vs. other published studies of ICD/CRT replacements (1.05%¹ vs. 2.60%² vs. 3.56%³).

1. Bloom H et al. PACE 2011;34(2):133-142  2. Krahn et al. Circ EP 2011;4(2):136-142  3. Gould et al. JAMA. 2006 295(16),1907-1911

Study Design: The CITADEL Study is a multicenter, prospective cohort study designed to define the clinical performance of the AIGISRx Antibacterial Envelope and Flat Sheet in patients undergoing CIED replacement with an implantable cardioverter defibrillator (ICD) device. www.ClinicalTrials.gov: CITADEL (NCT01043861)

Purpose: Define the clinical performance of the AIGISRx Antibacterial Envelope and Flat Sheet in patients undergoing CIED replacement with an ICD Device

Primary Endpoints: CIED mechanical complications and CIED infection

Patient Population: Patients > 18 years old who receive CIED implantation with an ICD who meet all inclusion/exclusion criteria

Length of Patient Follow-up: Up to 12 months

Patient Enrollment: The CITADEL Study is currently enrolling and is designed to enroll 2300 prospective patients in 50 sites

Study Design: The CENTURION Study is a multicenter, prospective cohort study designed to define the clinical performance of the AIGISRx Antibacterial Envelope and Flat Sheet in patients undergoing CIED replacement with a cardiac resynchronization therapy (CRT) device. www.ClinicalTrials.gov : CENTURION (NCT01043705)

Purpose: Define the clinical performance of the AIGISRx Antibacterial Envelope and Flat Sheet in patients undergoing CIED replacement with a CRT Device

Primary Endpoints: CIED mechanical complications and CIED infection

Patient Population: Patients > 18 years old who receive CIED implantation with a CRT device who meet all inclusion/exclusion criteria

Length of Patient Follow-up: Up to 12 months

Patient Enrollment: The CENTURION Study is currently enrolling and is designed to enroll 2000 prospective patients in 50 sites

Additional information regarding the efficacy of the combination of minocycline and rifampin in reducing infections in medical devices can be found at "Antibiotics” under “ Our Technology. ” 


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†AIGISRx reduction in infection is based on preclinical in vitro and in vivo data. Use of AIGISRx in contaminated wounds is not recommended. The device is not indicated for the treatment of infection.