Medtronic TYRX envelope cost-effective for patients with increased infection risk

Medtronic plc announced new data from the landmark WRAP-IT study, showing the TYRX Absorbable Antibacterial Envelope (TYRX Envelope) is cost effective for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs). The analysis, newly published in Circulation: Arrhythmia and Electrophysiology, demonstrates the envelope’s cost-effectiveness compared to standard-of-care infection prevention strategies in the U.S. healthcare system.

Cost-effectiveness analyses are tools to indicate which interventions provide good value for money. 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 $150,000, the recommended threshold of the American College of Cardiology/American Heart Association practice guidelines on cost/value methodology.

“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 Bruce Wilkoff, M.D., director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, lead author and a paid consultant to Medtronic. “These new data provide evidence that the envelope improves patient outcomes in a cost-efficient way.”

“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 Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “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.”

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.

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; experience an additional 9-18 days in the hospital; suffer impaired quality of life through six months; and pay approximately $2,000 in out-of-pocket costs to treat the infection. TYRX is the only intervention shown to significantly reduce CIED infection in addition to standard-of-care pre-operative antibiotics.

Importantly, based on the WRAP-IT results, an international consensus statement, supported by seven medical societies (including the Heart Rhythm Society) recommends TYRX for the WRAP-IT study population and for patients with high risk factors.

Cleveland Clinic named the Medtronic TYRX Envelope one of the Top 10 Medical Innovations for 2020. MPO