Success for the TYRX Absorbable Antibacterial Envelope in prevention of cardiac device site infections- Medtronic

Medtronic plc announced that its The TYRX Absorbable Antibacterial Envelope, reduces major cardiac device site infections by 80 percent, up to 12 months after implantation. These data were presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions in Boston. The Citadel/Centurion Clinical Trials are the first prospective, multicenter studies to evaluate the impact of the TYRX Antibacterial Envelope on cardiac implantable electronic device (CIED) major infections and mechanical complication rates following implantation in high-risk patients.

The results show a low rate of surgical site infection at 12 months (0.44 percent) in the 1,129 patients who received the TYRX Antibacterial Envelope compared with a control group of similar patients reported in previously published literature who did not receive an envelope (2.2 percent; p=0.0023). CIED infections are associated with substantial morbidity, mortality and cost and are increasing in frequency. The average cost of a CIED infection in the United States is estimated at $54,926.5.

Comment: The TYRX Absorbable Antibacterial Envelope, covering a cardiac implantable electronic device (CIED) such as a pacemaker, ICD or CRT device, releases rifampin and minocycline to the surgical site to help prevent infection. The envelope stabilizes the CIED, then dissolves and is fully absorbed approximately nine weeks after implantation. The TYRX Absorbable Antibacterial Envelope is currently cleared for use in the United States and approved in Canada and Israel and has a CE Mark .