FDA Clears Pacemaker Anti-Bacterial Envelope

The FDA granted 510(k) clearance for the AIGISRX CRMD Anti-Bacterial Envelope by Tyrxpharma, a cardiac rhythm medical device intended to immobilize and reduce bacterial infection of a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.

AIGISRX CRMD contains the antimicrobial agents rifampin and minocycline, 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), said the company.