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Medtronic TYRX™ Absorbable Antibacterial Envelope Is Cost Effective for Patients at Increased Risk of Infections
Cost-effectiveness analyses are tools to indicate which interventions provide good value for money.1 This pre-specified analysis of the global WRAP-IT Trial (Worldwide Randomized Antibiotic Envelope Infection Trial) compared costs and patient outcomes between patients who received the TYRX Envelope and patients who received standard-of-care. The TYRX Envelope is cost-effective in the WRAP-IT patient population, with its ICER (incremental cost effectiveness ratio*) well below the upper willingness to pay threshold of
"This analysis builds upon the results of the landmark WRAP-IT study, which showed use of the antibiotic envelope results in a significant reduction in infections, with no increase in complications," said
"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," said
Additional Study Results Published
Long-term results from WRAP-IT, recently published in Heart Rhythm, show that the effects of TYRX to reduce major CIED infection were sustained through three years of follow-up, which was driven by a significant reduction in pocket infections.3
Further, "impact of infection" data from the study, also published in Circulation: Arrhythmia and Electrophysiology, showed that patients who experience a major CIED infection are at a greater than threefold risk of death at one year compared to patients without an infection;4 experience an additional 9-18 days in the hospital;4,5 suffer impaired quality of life through six months;4 and pay approximately
Importantly, based on the WRAP-IT results, an international consensus statement, supported by seven medical societies (including the
About the WRAP-IT Clinical Trial
WRAP-IT compared the incidence of major infections in 6,983 patients whose CIED implantation included the TYRX Envelope (3,495) and patients whose procedure did not (3,488), with follow up through 12 months. Primary results published in
The study population included patients receiving a new cardiac resynchronization therapy defibrillator (CRT-D); and patients receiving a replacement, system revision or generator upgrade of an existing pacemaker, cardiac resynchronization therapy-pacemaker (CRT-P), implantable cardioverter defibrillator (ICD) or CRT-D. Patients with diabetes, previous history of infection, renal failure, and/or congestive heart failure also are at higher risk for CIED infections.
About the TYRX™ Absorbable Antibacterial Envelope
The TYRX Envelope is an absorbable single-use device that holds a cardiac implantable electronic device or implanted neurostimulator. It is designed to stabilize the device after implantation while releasing antimicrobial agents, minocycline and rifampin, over a minimum of seven days.9 Constructed from a multifilament, knitted absorbable mesh, the envelope is fully absorbed by the body approximately nine weeks after implantation.9,10 The device has a one-year shelf life in the
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
* ICER is a statistical summary of a healthcare intervention's cost effectiveness.
1 World Health Organization. Website – Cost effectiveness and strategic planning (WHO-CHOICE). Accessed
2 Anderson JL, et al. ACC/AHA Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures. Circulation. 2014;129:2329-2345.
3 Mittal S et al. Heart Rhythm. 2020 Jul;17(7):1115-1122
4 Wilkoff BL, et al. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ ArrhythmElectrophysiol. https://doi.org/10.1161/CIRCEP.119.008280
5 Sohail MR, et al. Arch Intern Med. 2011;171:1821-8.
6 Blomström-Lundqvist C, et al.
7 Cleveland Clinic Unveils Top 10 Medical Innovations for 2020. https://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations/Top-10-for-2020. Downloaded
9 Huntingdon Life Sciences Study TR-2013-001.
10 Sinclair Labs Study D13599.
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