Medtronic TYRX ™ Absorbable Antibacterial Envelope Is Effective at Reducing Infections in Cardiac Device Patients with Hematomas

Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced new data from the landmark WRAP-IT study published in Heart Rhythm, demonstrating a significantly lower infection risk for patients who develop hematomas after cardiac implantable electronic devices (CIEDs) when the TYRX ™ Absorbable Antibacterial Envelope (TYRX Envelope) is used at implant. The analysis showed an 82% reduction in major CIED infections among patients with the TYRX Envelope who developed hematomas compared to patients in the control group who developed hematomas.

An estimated 1.5 million patients worldwide receive a CIED every year, with 1% to 4% of these patients developing infections resulting in significant impacts on mortality, quality of life, healthcare utilization, and cost to global healthcare systems. Implant site hematoma, which is localized bleeding outside of the blood vessels, is a known complication of CIED procedures and can lead to device-related infections. Previous randomized controlled studies found a more than seven-fold risk of subsequent serious device-related infections in patients who develop a hematoma.

The current WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) analysis evaluated the incidence and consequences of hematomas and the association between TYRX Envelope use, hematomas, and major CIED infections among study patients (3,429 patients in control group; 3,371 patients in TYRX Envelope group). Patients with hematomas occurring within 30 days after the implant procedure were evaluated for subsequent infection risk. The incidence of hematomas was 2.2% (151 patients) and was similar among control and envelope patients.

The key findings, through 36 months of follow-up:

• In the control group, there was a greater than 11-fold increase in the risk of major infection among patients with hematoma vs. those without hematoma (13.1% vs. 1.6%; p<0.001).
• In envelope patients, the use of the TYRX Envelope reduced the risk of major infection among patients with hematoma: an 82% reduction in infection compared to control patients with hematoma (2.5% vs. 13.1%; p=0.03).

“Procedure-related hematomas are associated with serious consequences. This analysis sheds new light that these consequences can be significantly mitigated with the TYRX Envelope,” said Rob Kowal, M.D., PhD., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. “We look forward to additional data from WRAP-IT exploring the risk factors leading to procedure-related hematomas.”