Long-term Citadel/Centurion Clinical Trial Findings and Independent Data Presented at Heart Rhythm Society 36th Annual Scientific Sessions

DUBLIN and BOSTON - Medtronic plc (NYSE: MDT) today announced that its TYRX(TM) 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 literature1 who did not receive an envelope (2.2 percent; p=0.0023).


CIED infections are associated with substantial morbidity, mortality and cost2,3,4 and are increasing in frequency. The average cost of a CIED infection in the United States is estimated at $54,926.5

"Clinical studies show that the use of the TYRX Envelope is associated with a significant reduction in implant-related cardiac device site infections," said Charles A. Henrikson, M.D., M.P.H., FHRS, chief of electrophysiology at Oregon Health & Science University in Portland. "These new findings reveal that the TYRX Envelope decreases the rate of infections that can occur within the first year after implantation. This is very good news for patients, especially given the associated mortality and costs tied to CIED infection."

12-Month Results of Citadel/Centurion Clinical Trials
The Citadel/Centurion Clinical Trials enrolled 1,129 patients at 55 centers in the United States. Study participants were at high risk for infection because they were undergoing a CIED replacement procedure with either an implantable cardioverter-defibrillator (ICD) (Citadel) or a cardiac resynchronization therapy (CRT) device (Centurion). Primary endpoints were major CIED infection (involving any site other than skin or subcutaneous tissue of the incision, or endocarditis) and CIED mechanical complication over 12 months of follow-up. The frequency of CIED mechanical complications in patients implanted with the TYRX Envelope was low.

"These data support the long-term safety and efficacy of the TYRX Envelope and showcase the clinical benefit of this novel technology for cardiac device patients at increased risk for infection," said Marshall Stanton, M.D., vice president and general manager of the Tachycardia business, which is part of the Cardiac and Vascular Group at Medtronic.

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