AIGISRx® Antibacterial Envelope is indicated for holding a pacemaker or implantable cardioverter-defibrillator, (ICD), thereby creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotics that elute (dissolve) within a 7 to 10 day period.
The AIGISRx Antibacterial Envelope is the first FDA-cleared combination drug+device product designed to
Reduce infections associated with implantable pacemakers and/or ICDs, as demonstrated in preclinical in vitro and in vivo studies
Stabilize cardiac implantable electronic devices (CIEDs)
Summary of AIGISRx Benefits
- AIGISRx’s dual antibiotics effectively cover the majority of pathogens responsible for CIED infections
- Multiple Randomized Clinical Trials demonstrate that the minocycline/rifampin combination significantly reduces bacterial infections in four different types of medical devices
- AIGISRx site specific delivery is adjunctive to IV therapy
- Locally releases minocycline/rifampin antibiotics to help reduce the incidence of CIED-related infections
- Strong preclinical data supports the effectiveness of AIGISRx for reducing CIED-related infections --> FDA Clearance
- In vitro and in vivo animal models demonstrate efficacy vs. clinically relevant gram (+) and gram (-) pathogens
- Emerging Clinical Data
- COMMAND Study - published in PACE, February 2011
- CITADEL and CENTURION Studies in progress
- Extensive Operator Experience (> 25,000 units sold)
- AIGISRx has strong cost/benefit profile
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AIGISRx is designed in the shape of an envelope/pouch which carries or holds the implanted pacemaker and/or cardioverter defibrillator when placed into the surgically created “pocket.”
AIGISRx is a dual component (resorbable and nonresorbable), sterile prosthesis constructed of open-pore weave, knitted filaments of a lightweight polypropylene mesh and coated with a resorbable polymer.
The resorbable polymer carries two distinct antibiotics: 1) minocycline and 2) rifampin. Minocycline acts as a bacteriostatic to inhibit protein synthesis while rifampin acts as a bacteriocidal that inhibits DNA-dependent RNA polymerase. Both minocycline and rifampin are impregnated into the resorbable polymer in concentrations of 86µg/cm2.
Minocycline is a semisynthetic tetracycline derivative. Tetracyclines, including minocycline, have a similar antimicrobial spectrum against a wide range of Gram-positive and Gram-negative organisms.
Rifampin is a semisynthetic compound derived from Amycolatopsis rifamcinica. Rifampin has antimicrobial activity against select Gram-positive and Gram-negative organisms.
Once AIGISRx and either the pacemaker or defibrillator are placed into the surgically created pocket, the resorbable polymer begins to break down, releasing the 2 antibiotics. Minocycline and rifampin are released into the pocket for 7 to 10 days to help reduce the possibility of infection.
The resorbable polymer is resorbed by the body over the next approximately 140 days, leaving only the nonresorbable lightweight polypropylene mesh to hold and stabilize the device.
The resorbable polymer is composed of nontoxic or naturally occurring materials. Each component of the polymer has a history of prior human use or human exposure as implants, IV injectables, or foods. Many of the polymer components are GRAS (generally regarded as safe). Once introduced into an aqueous environment, the polymer matrix absorbs water, beginning the process which drives degradation and elution.
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AIGISRx reduction in infection is based on preclinical 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.