TYRX III Absorbable Antibacterial Envelope - Implantable pulse generator mesh bag, bioabsorbable

Intended purpose

The envelope is intended to securely hold a CIED, to reduce major CIED infection in patients at increased risk of infection as determined by the treating physician, and to improve CIED stability in patients with previous Twiddler's syndrome or recurrent lead dislodgement. The envelope is intended to be used with pacemakers and implantable defibrillators.

Functional description

The TYRX III Absorbable Antibacterial Envelope is a fully absorbable device designed to hold a cardiac implantable electronic device (CIED) securely to create a stable environment when implanted in the body. The envelope is constructed from multifilament knitted mesh that is composed of poly (glycolide-lactide) copolymer coated with an absorbable polyarylate polymer. The envelope’s absorbable polymer coating contains ancillary medicinal substances rifampicin and minocycline.