Antibacterial "Envelope” Protects Against Infection of Implanted Cardiac Devices

A new antibacterial device helps reduce infections associated with implanted cardiac rhythm management device (CRMD)-related endocarditis.

The AIGISRx Flat is a dual component (resorbable and nonresorbable) sterile prosthesis, designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body. The nonresorbable component is a large-pore monofilament polypropylene-mesh substrate, knitted from filaments similar in composition and diameter to 5-0 sutures; the knitted mesh comprises over 90% of the entire AIGISRx device (by weight). The mesh is coated with a bioresorbable, biocompatible polyarylate polymer (based upon the amino acid tyrosine) which breaks down linearly--primarily via hydrolysis--and is resorbed in approximately five months; the bioresorbable polymer breaks down into naturally occurring components which are considered Generally Regarded As Safe (GRAS).


The primary purpose of the polyarylate polymer is to act as a carrier for the antimicrobial agents minocycline and rifampin, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD-related endocarditis, including methicillin resistant Staphylococcus aureus (MRSA). The polyarylate and drug combination, which are spray coated onto the polypropylene mesh, comprise the remaining 10% of the entire AIGISRx device, by weight. The AIGISRx Flat is a product of TYRX (Monmouth Junction, NJ, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

"In patients who are undergoing battery change-outs, using the AIGISRx Flat option helps minimize dissection of the preexisting pocket,” said Heather Bloom, M.D., an assistant professor of medicine at Emory University School of Medicine (Atlanta, GA, USA). "Since the risk of infection is much higher in change-outs, partially due to the avascular pocket preventing tissue penetration by oral antibiotics, having a drug-eluting device on the site is of critical importance.”

"We anticipate the AIGISRx products will be adopted as the standard during CRMD implants procedures,” said Robert White, CEO of TYRX. "One of the great strengths of TYRX is the ability to leverage our current antibacterial technology into a wide variety of clinical applications. We are eager to help physicians and hospitals continue to address the significant unmet needs in infection control.”

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