Antibacterial envelope reduces infection, provides value to healthcare systems

Worldwide, an estimated 1.5 million patients receive a cardiovascular implantable electronic device (CIED) such as a pacemaker or implanted defibrillator each year. However, in approximately 1% to 4% of cases, CIED patients develop an infection, potentially as a result of bacteria introduced at the time of the implant surgery.^1,2

CIED procedure-related infections are associated with significant morbidity, mortality, and cost. According to recent research, these infections are linked to a greater than three-fold increase in death at 12 months and a disruption in therapy in more than one-third of patients.³

Furthermore, patients with an infection also may experience extended hospital stays (9 to 18 days on average) undergoing multiple procedures,^3,4 impaired quality of life for six months,³ and they pay approximately $2,000 in out-of-pocket costs to treat the infection.³ Hospitals spend, on average, $56,000 to $83,000 to manage each infection,^3-9 and reimbursement often does not cover all of a hospital’s costs.

As the COVID-19 pandemic continues to be a major health disruptor across our nation and around the world, reducing infections and hospital admissions are particularly important such that patients do not require supplemental care, and by extension, have reduced exposure for themselves and clinicians.

The Medtronic TYRX™ Absorbable Antibacterial Envelope is a synthetic mesh that elutes the antibiotics minocycline and rifampin. When implanted with a CIED or implanted neurostimulator, it stabilizes the device and reduces infection in high-risk patients before being fully absorbed into the body. Rigorous studies have demonstrated the envelope's clinical effectiveness and value to healthcare. 

The landmark WRAP-IT study (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial), involving nearly 7,000 patients, was the largest randomized, controlled, global CIED trial, demonstrating a 40% reduction of major CIED infections,² 61% reduction of device pocket infections,² and no increase in complications out to three years with TYRX.¹⁰
 
Additionally, an international consensus of seven medical societies awarded a “Green Heart” recommendation for the use of the TYRX Envelope¹¹ for the WRAP-IT patient population and patients with high-risk factors,^* further emphasizing the need for this novel technology and the critical issue it helps address. 

The TYRX Envelope is one way to help protect patients who receive CIEDs and implantable neurostimulators, and a groundbreaking value-based program utilizing the TYRX Envelope demonstrates its economic value to hospitals. The TYRX Outcomes Protection Program is a collaboration between Medtronic and more than 1,500 participating hospitals in the U.S. that helps share the economic burden in the event of a CIED infection when the TYRX Envelope was used during the implant procedure. This program is also active in several other countries around the globe.

Furthermore, economic analyses demonstrated the envelope’s cost-effectiveness compared to standard-of-care infection prevention strategies in the U.S.¹² and European¹³ healthcare systems, specifically, Germany, Italy, and the United Kingdom, showing its value to these systems by reducing the incidence of CIED infection. The absorbable antibacterial envelope is associated with a cost-effectiveness ratio in the WRAP-IT patient population below contemporary benchmarks set by the American College of Cardiology/American Heart Association practice guidelines on cost/value methodology.¹⁴

At Medtronic, we are committed to alleviating pain, restoring health and extending life, by engineering extraordinary solutions for patients and the institutions that serve them. To date, more than 675,000 patients globally have been protected by the TYRX Envelope.¹⁵ By reducing the risk of infections in these patients, TYRX has helped the healthcare system avoid more than $180 million (in USD) in infection-related healthcare costs.¹⁵ With the use of the TYRX Envelope to protect CIED and implantable neurostimulator patients around the world, we can continue to help reduce significant health care burdens associated with procedure-related infections.

Learn more about the TYRX Envelope and benefits to patients and hospitals at www.medtronic.com/envelope.

*The WRAP IT 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.

Medtronic (NYSE:MDT) is the leading global healthcare technology company. Our Mission — to alleviate pain, restore health, and extend life — unites a team of 90,000+ across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more.