Medtronic plc (NYSE:MDT) today announced results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), which demonstrated the TYRX(TM) Absorbable Antibacterial Envelope (TYRX envelope) reduced the risk of major infection by 40 percent, and pocket infection by 61 percent, in patients with cardiac implantable electronic devices (CIEDs), compared to standard-of-care pre-operative antibiotics. The trial results were presented today in a late-breaking session at the American College of Cardiology's 68th Annual Scientific Sessions (ACC.19), and published simultaneously in The New England Journal of Medicine.
"CIED infections are associated with significant morbidity, mortality and cost. Until now, in addition to adhering to strict surgical techniques, only one intervention, pre-operative antibiotics, has been shown to significantly reduce infections," said Khaldoun Tarakji , M.D., M.P.H., associate section head of cardiac electrophysiology at Cleveland Clinic, principal investigator of the trial, and a paid consultant to Medtronic. "This study shows that, in addition to pre-operative antibiotics, the use of the antibacterial envelope significantly reduced the risk of CIED infections, and with no increased risk of complications."
The trial met its primary endpoint showing effectiveness of the TYRX envelope in reducing major infections by 40 percent in patients at increased risk for infections resulting from CIED implantation: at 12 months, 1.2 percent of patients in the control group experienced a major infection, while only 0.7 percent of patients who received the TYRX envelope had a major infection (p=0.04). The trial also showed a 61 percent reduction in pocket infections with the envelope (p<0.01).
The TYRX envelope was successfully implanted in 99.7 percent of procedure attempts, with no significant difference in procedure time between the two groups. The trial also met its safety objective: the envelope did not increase the risk of procedure-related or system-related complications through 12 months (p<0.001 for non-inferiority).
Late-Breaking Trial Results Presented at ACC Scientific Sessions and Published in The New England Journal of Medicine
WRAP-IT is the Largest Randomized Global Trial Ever Conducted with Cardiac Implanted Electronic Devices
Editor's note: this press release originally appeared on Medtronic's website.
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