AIGISRx Clinical Data

 

AIGISRx Retrospective Registry – Completed

  • Multi-center, retrospective, consecutive case series with case-matched and historical control arms
  • 10 hospitals
  • Enrollment target: 500 patients. Endpoints: Implantation success & Infection
  • First Analyses presented during the 2009 TCT Meeting

See the Data

AIGISRx Prospective Registries – site recruitment underway

  • Multi-center, prospective, consecutive case series with case-matched and historical control arms
  • 20 hospitals
  • Enrollment: > 500 patients. Endpoints: Implantation success & Infection at f/u.

AIGISRx Explant Retrospective Registry – site recruitment underway

  • Multi-center, retrospective cohort study with a treatment arm (patients who required explant of a CRMD implanted with the AIGISRx), and a case-matched control arm (patients who required explant of a CRMD implanted without the AIGISRx.
  • Up to 54 clinical study sites
  • Enrollment: 54 patients per arm. Endpoints: Compare the technical difficulty of removing a CRMD in the presence or absence of the AIGISRx, and the proportion of CRMD-related infections caused by S. aureus when the CRMD is implanted with or without the AIGISRx.

 

AIGISRx Pre-clinical Data

 

In Vivo Infectivity Models Demonstrating AIGISRx Efficacy† 

  • Control: Pacemaker Alone
  • Treatment Arm: Pacemaker + AIGISRx (minocycline and rifampin)

Rabbit Study

 

 

Canine Study

 

AIGISRx Prevents Biofilm formation In Vivo


Acinetobacter species @ 7 days

 


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 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.