AIGISRX and CIED Stabilization

     

Keep Pacemakers and ICDs in Place, While Helping to Keep Infection Out

AIGISRx®  is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body1.

    •  TYRX's AIGISRx is constructed of a light-filament knitted polypropylene surgical mesh that is designed to hold and secure a cardiac implantable electronic device (CIED) and the proximal portion of associated leads.

    •  The polypropylene AIGISRx should not be confused with the polyester pouch (e.g., Dacron), which has been used in the past to help keep pacemakers and ICDs in place (e.g., Parsonnet™ Pouch).

Polypropylene, as found in AIGISRx, is less likely to cause the fibrosis one may find with a Dacron pouch

  • Clinical studies have shown polypropylene does not cause the intense chronic inflammation and subsequent fibrosis and encourages normal tissue growth.2,3

  AIGISRx®  Polypropylene Envelope                              Parsonnet™ Polyester Pouch 

 

AIGISRx is designed to encourage normal tissue ingrowth4

  • A 294-day, in vivo rabbit model demonstrated AIGISRx polypropylene mesh resulted in an ingrowth of "normal" tissue, while the polyethylene control was surrounded by a band of fibrous, scar-like tissue.4 

AIGISRx does not restrict future treatment approaches

  • AIGISRx can be safely removed at the time of revision/replacement procedure.

 AIGISRx Benefits

   • Ingrowth of tissue into the mesh of the AIGISRx Envelope that contains the device and proximal leads, is intended to reduce the chance of device migration or erosion.5

    • AIGISRx allows CIED and proximal leads to be neatly inserted into the implantation site, and may help decrease the possibility of lead damage during CIED replacement.

    • Tissue ingrowth into AIGISRx, rather than the CIED header and proximal leads, may help reduce the time typically spent exposing or releasing the leads during a replacement procedure.

  

Migration, Erosion, and Twiddler Syndrome

  • Cardiac Implantable Electronic Device (CIED) Migration can occur with frequency of 0.1% - 1.2%6,7.
  • CIED erosion and lead dislodgement can occur as a result of migration.
  • CIED migration or skin erosion typically results in the need to explant the device, deliver IV antibiotics, and re-implant a new device.8
  • Although this complication has been expected to decrease along with the weight and size of the CIEDs, generator migration (1.2%6) and lead dislodgement (2.96%7) continue to occur at clinically significant rates in current series of CIED implantations that utilize modern generators.
  • Twiddler Syndrome is a complication of CIED implantation with a frequency of 0.07% to 1.1%.9,10
  • Twiddler Syndrome is the intentional or unintentional twisting by the patient of the CIED within the implant pocket.  This may result in dislocation or fracture of the lead/electrode, diaphragmatic stimulation and the loss of capture.11,12

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      Photo courtesy of Roger Carrillo, MD, FHRS, University of Miami, Miller School of Medicine 

    1. TYRX IFU
    2. Parsonnet V et al. Pacing Clin Electrophysiol. 1994;17(2):2274-2278. 
    3. Marois Y et al. Artif Organs. 2000;24(7):533-543. 
    4. Data on file at TYRX. 
    5. Data on file at TYRX, Apptec rabbit study #36824 and canine study #49315.
    6. Kuhlkamp V et al. J Am Coll Cardiol. 2002;39(5):790-797.           
    7. Aggarwal RK et al. Br Heart J. 1995;73(6):571-575.
    8. Uslan DZ et al. Expert Rev Med Devices. 2008;5(2):183-195. 
    9. Fahraeus T et al. Europace. 2003;5(3):279-281. 
    10. Hill PE PACE. 1987;10(3 Pt.1):564-570. 
    11. Dursun I et al. Clin Res Cardiol. 2006:95(10):547-549. 
    12. Sullivan R. Revisiting Twiddler’s. HRS Poster Session, PO06-1, May 16, 2009.