Fridley, Minn.-based Medtronic designed its TYRX absorbable antibacterial envelope for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs).
Results from the WRAP-It study, published in Circulation: Arrhythmia and Electrophysiology, showcase the cost-effectiveness of the TYRX envelope compared to standard-of-care infection prevention strategies within the U.S. healthcare system, according to a news release.
Long-term results from the WRAP-IT study highlighted that using TYRX to reduce major CIED infections managed to sustain through three years of follow-up, which was driven by a reduction in pocket infections. The cost-effectiveness was demonstrated through incremental cost-effectiveness ratio, which came in well below the upper willingness to pay threshold of $150,000, Medtronic said.
The trial compared the incidence of major infections in 6,983 patients, 3,495 of whom received CIED implantation that included the TYRX envelope and 3,488 patients whose procedure did not, with follow-up through 12 months. Primary results showed that the TYRX envelope reduced the risk of major infection by 40% in patients with CIEDs and reduced pocket infections by 61%, compared to standard of care pre-operative antibiotics, while also reaching its safety objective of not increasing the risk of complications.
“We are committed to identifying and creating cost-effective innovations like the TYRX envelope that add value by reducing readmission rates, lowering infection risk, and decreasing hospitalizations,” Medtronic cardiac rhythm & heart failure division chief medical officer Dr. Rob Kowal said in the release. “During a global pandemic, reducing infections and readmissions is especially important because it means patients have fewer needs for supplemental medical care, which reduces the risk of exposure for themselves and their clinicians.”