Skip to main content
. 2015 Apr 10;4(1):53–57. doi: 10.15420/aer.2015.4.1.53

Table 2: Summary of clinical studies investigating the efficacy and safety of the TYRX Antibacterial Envelope.

Study type n Outcomes References
Retrospective cohort study, mean 1.9 months follow-up 634, 49 % had at least 3 risk factors CIED implantation was successful in 99.5 % of procedures. Major infections rate 0.48 after 1.9 ± 2.4 months follow-up. 51
Retrospective cohort study, min 90 days follow-up 260, mean 2.8 ± 1.2 risk factors One CIED infection among patients who received an antibacterial envelope (0.4 %), compared with 19 (3 %) in controls (odds ratio [95 % CI] 0.13 [0.02–0.95]; p=0.04. 52
Observational cohort study, consecutive patients 2,891 In the pre-envelope era, an infection occurred in 25 (1.5 %) of 1,651 patients. After its availability, an envelope was used in 275 (22 %) of 1,240 patients; an infection occurred in 8 (0.6 %) patients in this era (p=0.029 vs pre-envelope). 43
Prospective, observational multicentre cohort study, interim 180 day data available 1,000 Infection occurred in 0.2 % of patients who received the envelope compared with 1.9 % who did not receive the envelope (p <0.001). 55