AIGISRx™ Spec Sheet 

AIGISRx is an anti-bacterial envelope made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable  pacemaker or defibrillator when implanted in the body.

AIGISRx received FDA clearance as follows:

“AIGISRx is intended to securely hold the pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRx contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.”

Non-resorbable Mesh Substrate

A large pore mesh knitted from monofilament polypropylene filaments, similar in composition and diameter to 5-0 suture. The knitted mesh comprises over 90% of the entire AIGISRx device by weight.  

Resorbable Polymer Coating

A bioresorbable, biocompatible polymer based upon the amino acid, tyrosine, which breaks down linearly, primarily via hydrolysis and is resorbed in approximately 5 months. This bioresorbable polymer breaks down into naturally occurring components which are considered Generally Regarded As Safe (GRAS). The primary purpose of this polymer is to act as a carrier for the antimicrobial agents, minocycline and rifampin. The tyrosine polymer and drug combination, which are spray coated onto the polypropylene mesh, compromise the remaining 10% of the entire AIGISRx device by weight.

Antibiotics

Minocycline* dose per AIGISRx device: up to 11mg (Pacemaker),16mg (ICD). Sustained released over 7 to 10 days**. Minocycline is a bacteriostatic antimicrobial which inhibits protein synthesis of the cell wall.

Rifampin* dose per AIGISRx device: up to 11mg (Pacemaker), 16mg (ICD). Sustained released over 7 to 10 days**. Rifampin is a bacteriocidal antimicrobial which interferes with DNA-dependent RNA polymerase activity.

Minocycline has been shown to be effective against Gram + bacteria such as S Aureus and Strep Pneumonia and Gram – bacteria such as E Coli, E Aerogenes, H Influenza and Acinetobacter. Rifampin has been shown to be effective against Gram + bacteria such as S Aureus (including MRSA) and S Epidermidis and Gram – bacteria such as H Influenza.

AIGISRx PM Anti-Bacterial Pacemaker Envelope

Size: 2.5“ (6.5cm) x 2.75” (7.0cm)
SKU # CMRM-3122-S (box of 1 individual)
SKU # CMRM-3122-B (box of 6 individuals)
Single Use Only: Do Not Resterilize
Storage: Store between 36–77° F (2–25° C)
Each AIGISRx polymer-coated envelope is placed in a Tyvek folder 
insert which is packaged inside a single-barrier foil pouch.

AIGISRx ICD Anti-Bacterial Defibrillator Envelope

Size: 2.795” (7.1cm) x 3.1” (8.1cm)
SKU # CMRM-3133-S (box of 1 individual)
SKU # CMRM-3133-B (box of 6 individuals)
Single Use Only: Do Not Resterilize
Storage:  Store between 36–77° F (2–25° C)
Each AIGISRx polymer-coated envelope is placed in a Tyvek folder 
insert which is packaged inside a single-barrier foil pouch.

AIGISRx Polypropylene Mesh Mechanical Performance Properties
Burst Strength = 114 PSI
Tensile Strength =348 N  

*For full prescribing information see Minocycline and Rifampin package inserts.

**Based on in vitro and in vivo data of file.

For full prescribing information for AIGISRx, including warnings, cautions and contraindications, see package insert. 

AIGISRx is a trademark of TYRX, Inc.
Caution: Federal law restricts this device to sale by or on the order of a licensed medical practitioner.