AIGISRx™  Implant & Explant

 

AIGISRx Implant

  • Prepare the pulse generator or defibrillator as per manufacturer’s instructions, making sure to secure the leads.
  • Slide the pulse generator/defibrillator into the 1.38” opening in the pouch with lead wires emerging straight out asshown in Figure 1.
  • Place generator/defibrillator into the patient as per standard practice. If the dimensions of the pulsegenerator/defibrillator are larger than the 1.38” opening, but of similar dimension to the AIGISRx, the opening can bewidened to accommodate placement. (NOTE: AIGISRx cannot be used with generators and defibrillators that are larger than its internal dimensions.)
  • For generators and defibrillators that are significantly smaller than AIGISRx, the generator/defibrillator should be placed as shown in Figure 2.

Nonabsorbable or absorbable monofilament sutures can be used to tack the opening of the pouch to secure the generator/defibrillator prior to implantation.

 
  Figure 1        Figure 2

Note:  Some physicians have suggested that inserting the AIGISRx pouch or envelope into the patient’s surgically-created pocket first, and then inserting the generator/defibrillator, may be easier in some patients.  Also, physicians have reported that coiling and inserting the leads into the AIGISRx envelope after the AIGISRx envelope and the generator/defibrillator are in the patient pocket, may further simplify the implant procedure.

Removal/Replacement of Pulse Generator from AIGISRx

  • It may be necessary to remove the pacemaker or defibrillator from the pouch after a period of implantation.
  • First, surgically expose the pouch.
  • Make an incision on the flat side of the pouch, approximately the width of the pacemaker or defibrillator.
  • Disconnect the electrode leads.
  • Remove the pacemaker/defibrillator through the opening in the side of the pouch. If required, insert a drainage tube.
  • A new pacemaker/defibrillator may be inserted into the pouch through the side opening. Connect the electrical leads.
  • Suture the pouch closed.
  • Complete the procedure following standard accepted surgical techniques.
  • Familiarization with the device and following proper surgical techniques are important when explanting a device.

  • Always use standard of care subject to the patient’s condition and the surgical presentation in removing an implant.

    AIGISRx Explant 

    In vivo AIGISRx Explant

    • In both cases, using either scissors or a cautery knife, the ICD pocket and AIGISRx envelope were easily opened and the ICD was removed.
    • As is expected in humans, the level of tissue ingrowth differed in the two animals, and in one the AIGISRx could be removed through blunt dissection, and in the other the AIGISRx was removed by capsular excision.

      (An additional 8 canine, 6 month follow study is underway at Montreal Heart Institute.)

    AIGISRx Human Explant Data

    • In addition to TYRX’s ongoing AIGISRx Retrospective and Prospective Registries, TYRX has initiated an Explant Registry to further expand the collection of clinically relevant data. (see AIGISRx Clinical Data for more information)

    • Implanting AIGISRx to reduce infections does not restrict future treatment options

    • Removal of the AIGISRx during a pulse generator replacement is not required, (except in the case of an infection), and AIGISRx can be treated as part of the capsule scar that is naturally formed with all chronic CRMD implants
      - The presence of AIGISRx should not inhibit the enlargement of the capsule or pocket for a replacement with a larger device and/or a new AIGISRx

    • Implanting AIGISRx to reduce infections does not restrict treatment options later, and physician may consider the following explant approach options:



    For additional information regarding the biocompatibility of the AIGISRx polypropylene mesh, and how it differs from polyester, (e.g., Dacron), which has been used in the past for CRMD pouches (i.e. Parsonnet™ pouch), please visit Polypropylene Mesh at Our Technology .

    Also, any questions regarding AIGISRx implant or explant techniques are welcome by our Chief Medical Officer, Dr. Dan Lerner: dlerner@tyrx.com


    * Use of AIGISRx in contaminated wounds is not recommended. The device is not indicated for the treatment of infection.