Patients


Who Needs AIGIS?

The AIGISRx Anti-bacterial Envelope is a mesh pouch or envelope that carries or holds the implanted pacemaker and/or implantable cardioverter defibrillator (ICD) when placed into the patient.

The AIGISRx envelope creates a stable environment surrounding the device and leads after surgical placement and the biocompatible mesh is coated with antibiotics that elute (dissolve) within a 14 day-period.1



The AIGISRx envelope may be used for a patient’s first implant or when the pacemaker or ICD needs to be replaced, (battery life is typically 3 to 5 years).  The AIGIS delivers antibiotics “locally,” or at the surgical site, and can be used in addition to intravenous or oral (“systemic”) antibiotics. While all patients can potentially benefit from the AIGIS, 1 there are patients who are at higher risk for infections.2

Infection Risk Factors for Pacemaker and ICD Patients2-5

• Congestive Heart Failure (CHF) 

• Dialysis and pre-dialysis renal (kidney) failure                         

• Diabetes

• Immunosuppressed (including patients undergoing cancer therapy)

• (Cortico)steroid use

• Anticoagulant use

• Pacemaker or ICD replacement or revision

• Previous device infection


 

 

 

 

 

 

 

 

 

 

You and your Doctor will determine whether you could benefit from the AIGISRx envelope. To help with this conversation with your Doctor, the following “Discussion with your Doctor” guideline may be helpful:


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Discussion with Your Doctor:

Ask your doctor if you fall in any of the following risk categories:

Patient and procedure characteristics that significantly increase the risk of pacemaker or ICD-related infection (multivariate analyses):

 

Be prepared to answer the following questions from your Doctor:

  • Have you had any chest pain or shortness of breath?
  • Have you felt palpitations or a very irregular heartbeat?
  • Have you had any prior surgeries?
  • Have you experienced any infections?
  • What medications are you taking?
  • Notice anything unusual or unexpected, such as new symptoms?

Pacemaker or ICD Implant Follow-up Visit (in addition to the above questions)

   • What primary concerns do you have with your pacemaker or ICD?



   • Is your implant site painful to the touch? Yes  No 
   • Does your implant site feel warm to the touch? Yes  No 
   • Is the implant site area red and irritated? Yes  No 
   • Has your implant site leaked blood or pus? Yes  No 
   • Are the leads (wires) exposed or have the leads broken the skin? Yes  No 
   • Has your pacemaker changed or moved positions? Yes  No 
   • Other items you wish to discuss with your doctor?


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  1. 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.
  2. Sohail et al, Clin Infect Dis 2007 45, 166.
  3. Bloom et al, Pacing Clin Electrophysiol  2006 29(2), 142.
  4. Klug et al, Circulation 2007 116, 1349.
  5. Lekkerkerker et al, Heart 2009 95, 715.
  6. Kiviniemi et al, PACE 1999 22, 711.