AIGISRx^®  Implantation & Explantation

AIGISRx Implantation

• 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 as shown in Figure 1.
• Place generator/defibrillator into the patient as per standard practice. If the dimensions of the pulse generator/defibrillator are larger than the 1.38” opening, but of similar dimension to the AIGISRx, the opening can be widened 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 Envelope or Flat Sheet 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.

 AIGISRx Antibacterial Envelope “Can-In” Explantation Process

Explantation Approach*

The AIGISRx and CIED battery can be explanted using the following approach:

• Surface landmarks corresponding to the CIED generator are defined.
• The integrity of the AIGISRx is preserved by making an incision down to, but not through, the AIGISRx.  Dissection along the first available plane immediately external to the AIGISRx releases the AIGISRx containing the CIED generator from the surrounding tissue.  
• The AIGISRx, containing the CIED generator, is removed from the pocket.
• The CIED generator is removed from the AIGISRx through an incision and the AIGISRx is discarded.

To view the "Can-In" Explantation Process - Please click here

*TYRX is providing this information as part of an ongoing process to provide educational information for physicians.

Implanting AIGISRx to help prevent 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 CIED implants
• Implanting AIGISRx to help prevent infections does not restrict treatment options later, and physicians 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 CIED pouches (i.e. Parsonnet™ pouch), please visit Polypropylene Mesh at Our Technology .

Any questions regarding AIGISRx implantation or explantation techniques should be sent to info@tyrx.com .

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