FRIDLEY (dpa-AFX) - Medical technology firm Medtronic plc (MDT) announced Monday that new data from the landmark WRAP-IT study published in Heart Rhythm, demonstrated 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).
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 antibacterial agents, minocycline and rifampin, over a minimum of seven days.
Copyright RTT News/dpa-AFX
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